Drug recalls
Enforcement reports from the FDA's weekly recall database. Recalls are classified by the health hazard the defect presents: Class I where exposure is reasonably likely to cause serious harm or death, Class II where it may cause temporary or reversible harm, and Class III where it is unlikely to cause harm.
17,975 records · source: openFDA Enforcement
All classes 17,975 Class II 14,511 Class I 1,747 Class III 1,715 Not Yet Classified 2
| Class | Reported | Product | Reason | Firm | Status |
|---|---|---|---|---|---|
| Class II | November 12, 2014 | Obagi Nu-Derm Clear, AM PM 3, Skin Bleaching and Corrector Cream, Hydroquinone USP, 4%,… | Labeling: Label Mix-Up; Containers of the Obagi Nu-Derm Clear pre-labeled bottles were inadvertently introduced into… | Obagi Medical Products | Terminated |
| Class II | November 5, 2014 | Fentanyl injectable 6000 mcg/mL packaged in 30 mLor 60 mL syringes, Martin Avenue… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Atropine sulfate 2 mg/mL injectable packaged in an amber glass injectable vial, Martin… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Tri-mix, 30 mg/3 mg/5 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Tri-mix T108, 30 mg/1.5 mg/25 mcg/mL (papaverine, phentolamine mesylate, alprostadil)… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Vancomycin Hydrochloride Capsule, USP, 250 mg, 20 count blister pack, Rx Only, Mfd. for:… | Subpotent Drug | Actavis Inc | Terminated |
| Class II | November 5, 2014 | Tri-mix SEST 4, 30 mg/1.5 mg/400 mcg/mL (papaverine, phentolamine mesylate, alprostadil)… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Tri-mix ST9-E, 30 mg/4 mg/150 mcg/mL (papaverine, phentolamine mesylate, alprostadil)… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Tri-mix T101, 17.65 mg/0.59 mg/5.9 mcg/mL (papaverine, phentolamine mesylate,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Hydroxyzine hydrochloride 25 mg/mL injectable packaged in an amber glass injectable vial,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Hydromorphone/clonidine/bupivacaine 12 mg/600 mcg/0.2 mg/mL injectable packaged in 30 mL… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Acetylcysteine 20% (PF) inhalant solution packaged in either a 3 mL or 7 mL vial, Martin… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Hydroxocobalamin 5 mg/mL injectable packaged in an amber glass injectable vial, Martin… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Hydromorphone HCl/bupivacaine (PF) 10 mg/7.5 mg/mL injection packaged in 30 mL or 60 mL… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Alprostadil alcohol 500 mcg/mL injectable packaged in amber glass injectable vial, Martin… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Testosterone cypionate 250 mg/mL injection packaged in an amber glass injectable vial,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Morphine sulfate (PF) 20 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Tri-mix T105, 30 mg/1 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil)… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Methylcobalamin 10 mg/mL injectable packaged in an amber glass injectable vial, Martin… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Atropine sulfate 0.5% opthalmic solution packaged in a squeeze bottle eye dropper, Martin… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class III | November 5, 2014 | APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-count HDPE… | Labeling: Incorrect or Missing Package Insert | Valeant Pharmaceuticals North America LLC | Terminated |
| Class II | November 5, 2014 | Quad mix 1, 12 mg/1 mg/10 mcg/0.15 mg/mL (papaverine, phentolamine mesylate, alprostadil,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Tri-mix, 30 mg/2 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | PGE 2, 100 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Bacteriostatic water for injection packaged in an amber glass injectable vial, Martin… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Nalbuphine 10 mg/mL injection solution packaged in an amber glass injectable vial, Martin… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Voriconazole 10 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Dexamethasone sodium phosphate 4 mg/mL injectable packaged in an amber glass injectable… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Hydromorphone HCl (PF) 1 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Sodium tetradecyl sulfate 5% (PF) injectable packaged in an amber glass injectable vial,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Chorionic gonadotropin buffered diluent solution packaged in an amber glass injectable… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count bottle,… | Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point. | West-Ward Pharmaceutical Corp. | Terminated |
| Class II | November 5, 2014 | All products, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar… | Lack of Assurance of Sterility | Specialty Compounding, LLC | Terminated |
| Class II | November 5, 2014 | Glycerin 72% (w/v) sodium chloride injectable packaged in an amber glass injectable vial,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Tri-mix T102, 17.65 mg/0.59 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil)… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Cefazolin forte 50 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Fentanyl/bupivacaine 3000 mcg/30 mg/mL injectable packaged in 30 mL or 60 mL syringes,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Phenol 10% injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Methylcobalamin 25 mg/mL injectable packaged in an amber glass injectable vial, Martin… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Chorionic gonadotropin/mannitol 10000 U/0.1 gm powder packaged in a white jar, Martin… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Tri-mix T50, 8.825 mg/0.29 mg/2.95 mcg/mL (papaverine, phentolamine mesylate,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Tobramycin (PF) 15 mg/mL opthalmic solution packaged in opaque squeeze bottle eye… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Testosterone cypionate 150 mg/mL injection packaged in an amber glass injectable vial,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Cromolyn sodium 1% inhalant solution packaged in a 3 mL or 7 mL vial, Martin Avenue… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Tri-mix ST9-A, 30 mg/2 mg/80 mcg/mL (papaverine, phentolamine mesylate, alprostadil)… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Pilocarpine (PF) 0.25% opthalmic solution packaged in an opaque squeeze bottle eye… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Hydromorphone/bupivacaine (PF) 0.5 mg/0.2 mg/mL injectable packaged in 30 mL or 60 mL… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Sodium tetradecyl sulfate 2% (PF) injectable packaged in an amber glass injectable vial,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Triamcinolone acetonide (PF) 40 mg/mL injection suspension packaged in an amber glass… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Dihydroergotamine mesylate 1 mg/mL injection solution packaged in an amber glass… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Opthalmic ointment base ointment packaged in a white ointment tube, Martin Avenue… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Sodium tetradecyl sulfate 3% (PF) injectable packaged in an amber glass injectable vial,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Phenylephrine 10% opthalmic solution packaged in an opaque squeeze bottle eye dropper,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | CVS pharmacy, Pain Relieving Antiseptic Spray. Benzalkonium Cl 0.13% Lidocaine HCl 2.5% 5… | Microbial Contamination of Non-Sterile Products: CVS Pharmacy Pain Relieving Antiseptic Spray tested positive for… | Wisconsin Pharmacal Company | Terminated |
| Class II | November 5, 2014 | Lidocaine 1% injectable packaged in an amber glass injectable vial, Martin Avenue… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Phenylephrine 1% injectable packaged in an amber glass injectable vial, Martin Avenue… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Triamcinolone acetonide suspending vehicle (PF) vehicle packaged in an amber glass… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Tri-mix, 30 mg/0.5 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil)… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Trimethoprim/sulfadiazine excipient stock solution injection packaged in an amber glass… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Polyhexamethylene biguanide 0.02% opthalmic solution packaged in an opaque squeeze bottle… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | PGE 1, 40 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Chlorhexidine gluconate 0.02% opthalmic solution packaged in an opaque squeeze bottle eye… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Calcium chloride (PF) 100 mg/mL injectable packaged in an amber glass injectable vial,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Phentolamine mesylate 5 mg/35 mg/mannitol trituration packaged in a white jar, Martin… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Quad mix 2, 12 mg/1 mg/25 mcg/0.25 mg/mL (papaverine, phentolamine mesylate, alprostadil,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class I | November 5, 2014 | CALCIUM GLUCONATE 2 gm (PF) PRESERVATIVE FREE in 100 mL Sodium Chloride 0.9% for… | Non Sterility: Microbial contamination | Specialty Compounding, LLC | Terminated |
| Class II | November 5, 2014 | Vancomycin 50 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Quad mix, 30 mg/1 mg/10 mcg/0.15 mg/mL (papaverine, phentolamine mesylate, alprostadil,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Tetracycline 250 mg powder kits packaged with powder and water in separate amber glass… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only, Mfd. for:… | Subpotent Drug | Actavis Inc | Terminated |
| Class II | November 5, 2014 | Tri-mix ST5, 30 mg/1.5 mg/300 mcg/mL (papaverine, phentolamine mesylate, alprostadil)… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Methylcobalamin (PF) 25 mg/mL injectable packaged in an amber glass injectable vial,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | PGE 4, 300 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Peng/proc/strep/chlor/hyos (penicillin G, procaine, streptomycin sulfate,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Paraben water for injection packaged in a sterile 1000 mL clear bottle, Martin Avenue… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class III | November 5, 2014 | APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 348 mg, a) 7-count HDPE… | Labeling: Incorrect or Missing Package Insert | Valeant Pharmaceuticals North America LLC | Terminated |
| Class III | November 5, 2014 | APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count HDPE… | Labeling: Incorrect or Missing Package Insert | Valeant Pharmaceuticals North America LLC | Terminated |
| Class II | November 5, 2014 | Tri-mix, 15 mg/0.5 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil)… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Quad mix, 9 mg/1 mg/10 mcg/0.1 mg/mL (papaverine, phentolamine mesylate, alprostadil,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Methylcobalamin 1 mg/mL injectable packaged in an amber glass injectable vial, Martin… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Morphine sulfate (PF) 3 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Sodium tetradecyl SO4 stock solution 6% solution packaged in an amber glass injectable… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Atropine sulfate 1 mg/mL injectable packaged in an amber glass injectable vial, Martin… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Hyaluronidase base vehicle (PF) solution packaged in an amber glass injectable vial,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Tri-mix 8.3 low dose, 22 mg/0.83 mg/8.3 mcg/mL (papaverine, phentolamine mesylate,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Vancomycin 25 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | PGE 2.5, 150 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Polyhexamethylene biguanide 2% stock solution packaged in an opaque squeeze bottle eye… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Cyclosporine 200 mg/mL opthalmic suspension packaged in an amber glass injectable vial,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Acetylcysteine 10% opthalmic solution packaged in an opaque squeeze bottle eye dropper,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Lidocaine 2% injectable packaged in an amber glass injectable vial, Martin Avenue… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Tri-mix, 12 mg/1 mg/9 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Cefazolin forte 25 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Histamine 2.75 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Tri-mix T106, 30 mg/1 mg/25 mcg/mL (papaverine, phentolamine mesylate, alprostadil)… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Atropine sulfate 0.01% opthalmic solution packaged in a squeeze bottle eye dropper,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Methylcobalamin (PF) 1 mg/mL injectable packaged in an amber glass injectable vial,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Tri-mix, 30 mg/1 mg/20 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Tri-mix ST1, 30 mg/1.5 mg/50 mcg/mL (papaverine, phentolamine mesylate, alprostadil)… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Hydrochloric acid/water for injection 10% (w/v) packaged in an amber glass dropper… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Cyclosporine suspending vehicle packaged in an amber glass injectable vial, Martin Avenue… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC… | Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the… | Hi-Tech Pharmacal Co., Inc. | Terminated |
| Class II | November 5, 2014 | Cyclosporine/corn oil stock vehicle oil packaged in an amber glass injectable vial,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Benzalkonium chloride water for injection packaged in an amber glass injectable vial,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Lidocaine (PF) 1% injectable packaged in an amber glass injectable vial, Martin Avenue… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Quad mix, 30 mg/1 mg/20 mcg/0.15 mg/mL (papaverine, phentolamine mesylate, alprostadil,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Sodium tetradecyl sulfate 1% (PF) injectable packaged in an amber glass injectable vial,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | PGE 20 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Testosterone cypionate 200 mg/mL injection packaged in an amber glass injectable vial,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | PGE 3, 200 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Acetylcysteine 10% (PF) inhalant solution packaged in either a 3 mL or 7 mL vial, Martin… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Fentanyl injectable 2000 mcg/mL packaged in 30 mL or 60 mL syringes, Martin Avenue… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | "NB2014" 30 mg/6 mg/300 mcg/0.3 mg/mL (phentolamine mesylate, papaverine, alprostadil,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Morphine/bupivacaine 5 mg/2 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Diazepam 5 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Tri-mix, 30 mg/2 mg/20 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Bupivacaine hydrochloride 0.25% injectable packaged in an amber glass injectable… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Prednisolone acetate 50 mg/mL injectable packaged in an amber glass injectable vial,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Hyaluronidase injection solution (PF) 150 U/mL injectable packaged in an amber glass… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Quad mix, 18 mg/0.2 mg/10 mcg/0.02 mg/mL (papaverine, phentolamine mesylate, alprostadil,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Tri-mix ST2, 30 mg/3 mg/100 mcg/mL (papaverine, phentolamine mesylate, alprostadil)… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Rescue solution with triamcinolone (lidocaine, bupivacaine, heparin, triamcinolone)… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Histamine 0.55 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Tri-mix ST9-B, 30 mg/2 mg/100 mcg/mL (papaverine, phentolamine mesylate, alprostadil)… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Tacrolimus oil 0.03% opthalmic solution packaged in an opaque squeeze bottle eye dropper,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Hydroxocobalamin 10 mg/mL injectable packaged in an amber glass injectable vial, Martin… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Dexamethasone sodium phosphate 24 mg/mL injectable packaged in an amber glass injectable… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Cyanocobalamin 1000 mcg/mL injectable solution packaged in an amber glass injectable… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class II | November 5, 2014 | Tri-mix T25, 4.413 mg/0.145 mg/1.475 mcg/mL (papaverine, phentolamine mesylate,… | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile… | Martin Avenue Pharmacy, Inc. | Terminated |
| Class I | November 5, 2014 | CUBICIN (daptomycin for injection) 500 mg, For Intravenous Use Only, Rx Only, Single use… | Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial… | Cubist Pharmaceuticals, Inc. | Terminated |
| Class II | November 5, 2014 | Glimepiride GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 500 count… | Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability… | Micro Labs Usa, Inc S | Terminated |
| Class II | November 5, 2014 | Emtriva (emtricitabine) Oral Solution, 10 mg/mL, 170 mL bottles, Rx only, Manufactured… | Defective Container; leaking around the cap | Gilead Sciences, Inc. | Terminated |
| Class III | November 5, 2014 | Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufactured by:… | Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made… | Taro Pharmaceuticals U.S.A., Inc. | Terminated |
| Class II | November 5, 2014 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND… | Failed Impurities/Degradation Specifications: Out of specification for unknown impurities. | Teva Pharmaceuticals USA | Terminated |
| Class II | October 29, 2014 | Rugby Children's Pain and Fever Acetaminophen Oral Suspension 160 mg/5 mL, Cherry Flavor,… | Superpotent Drug: Bio-Pharm, Inc. is initiating a recall of one lot of Acetaminophen Oral Suspension Liquid 160mg/5mL… | Bio-pharm, Inc. | Terminated |
| Class II | October 29, 2014 | CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, CHERRY FLAVOR, Active ingredient (in… | Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension… | Qualitest Pharmaceuticals | Terminated |
| Class II | October 29, 2014 | ZEE Aspirin 325mg - 24 tablets in single dose packets, OTC, Manufactured for ZEE Medical… | Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listing of inactive… | Zee Medical Products Inc | Terminated |
| Class II | October 29, 2014 | Assured Aspirin Enteric Safety Coated Tablets, 81 mg, Adult Low Strength, Pain Reliever… | Subpotent Drug: Product failed to meet USP Specifications on assay, content uniformity, and dissolution. | American Family Pharmacy, LLC | Terminated |
| Class II | October 29, 2014 | CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active ingredient… | Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension… | Qualitest Pharmaceuticals | Terminated |
| Class II | October 29, 2014 | Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/carton, and 12… | Failed Dissolution Specification; at the 6-month stability time point | Forest Pharmaceuticals Inc | Terminated |
| Class II | October 29, 2014 | CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, GRAPE FLAVOR, Active ingredient (in… | Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension… | Qualitest Pharmaceuticals | Terminated |
| Class II | October 29, 2014 | Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex… | Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg | Aidarex Pharmaceuticals LLC | Terminated |
| Class II | October 29, 2014 | MUSTARCREME, Net Contents: 60g (21 oz) Country of Origin Guyana. | Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing,… | New Gpc Inc. | Terminated |
| Class II | October 29, 2014 | alcosulph Moisturizing Cream, Net Contents: 60g. Product packaged within a plastic… | Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing,… | New Gpc Inc. | Terminated |
| Class II | October 29, 2014 | Ferrol EXPECTORANT, Net Contents: 100 mL. Product packaged within a plastic bottle… | Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing,… | New Gpc Inc. | Terminated |
| Class II | October 29, 2014 | WHITFIELD LOTION, Net Contents: 60 mL. Manufactured by: NEW GPC INC. A1 Farm, EBD.… | Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing,… | New Gpc Inc. | Terminated |
| Class II | October 29, 2014 | alcosulph Astringent Lotion, Net Contents: 1) 60 mL and 2) 120 mL. Product packaged… | Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing,… | New Gpc Inc. | Terminated |
| Class II | October 29, 2014 | Whitfield's OINTMENT B.P., Net Contents: 15g. Manufactured by: NEW GPC INC. A1 Farm, EBD.… | Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing,… | New Gpc Inc. | Terminated |
| Class II | October 29, 2014 | Rector's Remedy OINTMENT, Net Contents: 15g. Manufactured by: NEW GPC INC. A1 Farm, EBD.… | Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing… | New Gpc Inc. | Terminated |
| Class II | October 29, 2014 | HYDROMORPHONE HYDROCHLORIDE Hydromorphone Hydrochloride Injection, USP, 10 mg/mL, Rx only, packaged in a) 1 mL… | Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or… | Hospira Inc. | Terminated |
| Class III | October 29, 2014 | methylprednisolone MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and Distributed… | Subpotent; 6 month stability time point | American Health Packaging | Terminated |
| Class II | October 22, 2014 | Clonidine HCL, 97 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation,… | cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy… | Gyma Laboratories Of Amer,Inc | Terminated |
| Class III | October 22, 2014 | Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100… | Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset | Valeant Pharmaceuticals North America LLC | Terminated |
| Class II | October 22, 2014 | Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines… | cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy… | Gyma Laboratories Of Amer,Inc | Terminated |
| Class II | October 22, 2014 | HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE.… | Crystallization: Formation of crystals observed in product. | Avella of Deer Valley, Inc. | Terminated |
| Class II | October 22, 2014 | Atorvastatin Calcium 40 MG Tablet, MFG: Apotex NDC# 6050525808 | Presence of Foreign Tablets/Capsules:179 doses of Valacyclovir HCl 500 mg tablets were repacked in unit dose… | Unit Dose Solutions Inc | Terminated |
| Class III | October 22, 2014 | Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, Manufactured… | Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test… | Valeant Pharmaceuticals International | Terminated |
| Class II | October 22, 2014 | Propranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines… | cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy… | Gyma Laboratories Of Amer,Inc | Terminated |
| Class II | October 22, 2014 | Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines… | cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy… | Gyma Laboratories Of Amer,Inc | Terminated |
| Class III | October 22, 2014 | Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for:… | Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test… | Valeant Pharmaceuticals International | Terminated |
| Class III | October 22, 2014 | Vasotec Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals… | Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert. | Valeant Pharmaceuticals North America LLC | Terminated |
| Class II | October 22, 2014 | KETOROLAC TROMETHAMINE Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2… | Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling… | Sagent Pharmaceuticals Inc | Terminated |
| Class I | October 22, 2014 | Lidocaine Hydrochloride Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Single-Dose Vial,… | Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the… | Hospira Inc. | Terminated |
| Class II | October 22, 2014 | topiramate TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare… | Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets. | Zydus Pharmaceuticals USA Inc | Terminated |
| Class II | October 15, 2014 | METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), 10 mL cups,… | Defective Container: Product leaks when inverted. | VistaPharm, Inc. | Terminated |
| Class II | October 15, 2014 | All sterile products within expiry | Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of… | Unique Pharmaceutical, Ltd | Terminated |
| Class II | October 15, 2014 | amiodarone hydrochloride Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only,… | Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature… | Mckesson | Terminated |
| Class II | October 15, 2014 | Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by:… | Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample. | Janssen Ortho L.L.C. | Terminated |
| Class I | October 15, 2014 | N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133 | Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense. | Unique Pharmaceutical, Ltd | Terminated |
| Class II | October 15, 2014 | Atenolol ZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufactured by: Cadila… | Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in… | Zydus Pharmaceuticals USA Inc | Terminated |
| Class II | October 15, 2014 | Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers… | Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the… | Astellas Pharma US Inc | Terminated |
| Class III | October 15, 2014 | Truvada Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count… | Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates. | Gilead Sciences, Inc. | Terminated |
| Class II | October 15, 2014 | Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg… | Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of… | Mylan Pharmaceuticals Inc. | Terminated |
| Class III | October 15, 2014 | E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -count box, Rx… | Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months. | Bracco Diagnostic Inc | Terminated |
| Class II | October 8, 2014 | Creon CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule… | Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000. | AbbVie Inc | Terminated |
| Class I | October 8, 2014 | MOJO RISEN, 650 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT… | Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil. | Eugene Oregon, Inc. | Terminated |
| Class I | October 8, 2014 | Black Ant, 2800 mg, four capsules per box, Manufacturer Qinghai Baojiantang… | Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil. | Eugene Oregon, Inc. | Terminated |
| Class I | October 8, 2014 | AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei… | Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil. | Eugene Oregon, Inc. | Terminated |
| Class II | October 8, 2014 | All sterile drugs compounded between 2/21/14 and 2/24/14. | Lack of Assurance of Sterility: All compounded products. | New England Home Therapies, Inc | Terminated |
| Class I | October 8, 2014 | CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for:… | Presence of Particulate Matter: Potential presence of glass particulate matter in the vials. | Cubist Pharmaceuticals, Inc. | Terminated |
| Class II | October 8, 2014 | Zoledronic Acid Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in… | Lack of Assurance of Sterility; leaking of premix bags | Sagent Pharmaceuticals Inc | Terminated |
| Class II | October 8, 2014 | Dopamine Hydrochloride and Dextrose DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA,… | Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing… | Baxter Healthcare Corp. | Terminated |
| Class II | October 8, 2014 | Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle,… | Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. | Actavis Laboratories, FL, Inc. | Terminated |
| Class II | October 8, 2014 | Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle,… | Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. | Actavis Laboratories, FL, Inc. | Terminated |
| Class I | October 8, 2014 | DIANEAL LOW CALCIUM WITH DEXTROSE Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL… | Presence of Particulate Matter: particulate matter was found during the manufacturing process. | Baxter Healthcare Corp. | Terminated |
| Class I | October 8, 2014 | Marcaine Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg)… | Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles… | Hospira Inc. | Terminated |
| Class II | October 1, 2014 | Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Only.… | Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uniformity of Dosage… | Alvogen, Inc | Terminated |
| Class III | October 1, 2014 | Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by… | Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point. | Apotex Corp. | Terminated |
| Class III | October 1, 2014 | Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx… | Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month… | Akorn, Inc. | Terminated |
| Class II | October 1, 2014 | Daytrana Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 hours… | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value… | Noven Pharmaceuticals, Inc. | Terminated |
| Class II | October 1, 2014 | Buprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10 Carpuject Sterile… | Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the… | Hospira Inc. | Terminated |
| Class II | October 1, 2014 | POTASSIUM CHLORIDE Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL… | Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained… | Baxter Healthcare Corp | Terminated |
| Class III | October 1, 2014 | methylprednisolone MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21) and b) 21… | Subpotent; 6 month stability time point | Qualitest Pharmaceuticals | Terminated |
| Class I | September 24, 2014 | Oxcarbazepine Tablets, 300 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and… | Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards… | American Health Packaging | Terminated |
| Class I | September 24, 2014 | Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and… | Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards… | American Health Packaging | Terminated |
| Class II | September 24, 2014 | NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible Bag, Rx… | Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopened bag of Sodium… | Unique Pharmaceutical, Ltd | Terminated |
| Class I | September 24, 2014 | COUMADIN FOR INJECTION (Warfarin Sodium for Injection, USP 5 mg Single-Use Vial Rx Only… | Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic cellulose fiber… | Bristol-Meyers Squibb | Terminated |
| Class I | September 24, 2014 | XZEN PLATINUM, 750 mg, 1 capsule per blister pack, Distributed by: XZEN, City of Los… | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN… | Nova Products, Inc. | Terminated |
| Class II | September 24, 2014 | Dermatend Ultra, mole, wart and skin tag remover, For external use only, Ingredient:… | Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to be safe… | Solace International Inc | Terminated |
| Class I | September 24, 2014 | MOJO RISEN ,670 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT… | Marketed Without an Approved NDA/ANDA; Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling AFRICAN… | Nova Products, Inc. | Terminated |
| Class II | September 24, 2014 | Dermatend Original, mole, wart and skin tag remover, For external use only, Ingredient:… | Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to be safe… | Solace International Inc | Terminated |
| Class I | September 24, 2014 | Xzone 1200, 750 mg, one capsule per blister pack, Distributed by: Xzone, Orlando, FL 32789 | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZone… | Nova Products, Inc. | Terminated |
| Class I | September 24, 2014 | AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei… | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling AFRICAN… | Nova Products, Inc. | Terminated |
| Class I | September 24, 2014 | Black Ant, 4600 mg, four capsules per box, , Manufacturer Timpo Bioengineering Co., Ltd,… | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Black Ant… | Nova Products, Inc. | Terminated |
| Class I | September 24, 2014 | XZEN GOLD,750 mg, six capsules per bottle, Distributed by: XZEN, City of Los Angeles, CA… | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN GOLD… | Nova Products, Inc. | Terminated |
| Class I | September 24, 2014 | XZONE GOLD, 750 mg, one capsule blister pack, Distributed by: XZONE, Orlando, FL 32789 | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZONE GOLD… | Nova Products, Inc. | Terminated |
| Class I | September 24, 2014 | Xzen 1200, 750 mg, six capsules per bottle, Distributed by: xzen, City of Los Angeles, CA… | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Xzen 1200… | Nova Products, Inc. | Terminated |
| Class III | September 24, 2014 | Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx… | Failed Impurity/Degradation Specification; high out of specification for CAD II degradant | Apotex Corp. | Terminated |
| Class I | September 24, 2014 | THINOGENICS, WEIGHT LOSS MADE EASY! DIETARY SUPPLEMENT, 30 CAPSULES, 30 Count Bottles,… | Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine. | Nature's Universe | Terminated |
| Class III | September 24, 2014 | Warfarin Sodium Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100 and 1000 Tablet Bottles, Rx Only.… | Failed Content Uniformity Specifications. | Taro Pharmaceuticals U.S.A., Inc. | Terminated |
| Class I | September 24, 2014 | SODIUM CHLORIDE 0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC… | Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. | Baxter Healthcare Corp. | Terminated |
| Class I | September 24, 2014 | POTASSIUM CHLORIDE Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag,… | Presence of Particulate Matter: particulate matter identified as fibers and/or plastics | Baxter Healthcare Corp. | Terminated |
| Class I | September 24, 2014 | Sodium Chloride 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose… | Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. | Baxter Healthcare Corp. | Terminated |
| Class II | September 24, 2014 | Bupivacaine Hydrochloride Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve… | Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle… | Hospira Inc. | Terminated |
| Class III | September 17, 2014 | CHIROTHIN Dietary Supplement, 2 Fl Oz (60 ml), OTC. Manufactured for ChiroNeutraceutical,… | Marketed without an Approved NDA/ANDA; Product contains unapproved hHCG. | ChiroNutraceutical LLC | Terminated |
| Class II | September 17, 2014 | SODIUM CHLORIDE 0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthcare… | Lack of Assurance of Sterility; complaints of mold in the overpouch | Baxter Healthcare Corp. | Terminated |
| Class II | September 10, 2014 | PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only,… | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with… | Apotex Inc. | Terminated |
| Class II | September 10, 2014 | PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle, Rx only,… | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with… | Apotex Inc. | Terminated |
| Class II | September 10, 2014 | OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured… | Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles. | Qualitest Pharmaceuticals | Terminated |
| Class II | September 10, 2014 | PAXIL (Paroxetine HCL) Tablets 20 mg, 30-count bottle, Rx only, Manufactured by… | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with… | Apotex Inc. | Terminated |
| Class II | September 10, 2014 | PAXIL (Paroxetine HCL) Tablets 10 mg, 30-count bottle, Rx only, Manufactured by… | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with… | Apotex Inc. | Terminated |
| Class II | September 10, 2014 | PAXIL (Paroxetine HCL) Tablets 40 mg, 30-count bottle, Rx only, Manufactured by… | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with… | Apotex Inc. | Terminated |
| Class II | September 10, 2014 | PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Manufactured… | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with… | Apotex Inc. | Terminated |
| Class II | September 10, 2014 | Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured… | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with… | Apotex Inc. | Terminated |
| Class II | September 10, 2014 | Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80, b) 24… | Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for… | Sage Products Inc | Terminated |
| Class II | September 10, 2014 | Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured… | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with… | Apotex Inc. | Terminated |
| Class II | September 10, 2014 | Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, Manufactured… | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with… | Apotex Inc. | Terminated |
| Class I | September 3, 2014 | del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Pharmacy… | Non Sterility; microbial contamination identified as Aspergillus species | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class I | September 3, 2014 | Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon… | Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. | Pharmakon Pharmaceuticals | Terminated |
| Class I | September 3, 2014 | adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pharmacy… | Non Sterility; microbial contamination identified as Aspergillus species | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class I | September 3, 2014 | MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX | Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis | Abrams Royal Pharamacy | Terminated |
| Class III | September 3, 2014 | Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan… | Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during… | Mylan Pharmaceuticals Inc. | Terminated |
| Class I | September 3, 2014 | Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled… | Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. | Pharmakon Pharmaceuticals | Terminated |
| Class II | September 3, 2014 | Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals,… | Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. | Pharmakon Pharmaceuticals | Terminated |
| Class I | September 3, 2014 | PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services, Inc.,… | Non Sterility; microbial contamination identified as Aspergillus species | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class I | September 3, 2014 | Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only.… | Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. | Pharmakon Pharmaceuticals | Terminated |
| Class III | September 3, 2014 | Famotidine Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not… | Failed Impurity/Degradation Specification; 12-month stability time point | Novel Laboratories, Inc. | Terminated |
| Class II | September 3, 2014 | All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX | Lack of Assurance of Sterility | Abrams Royal Pharamacy | Terminated |
| Class I | September 3, 2014 | LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Services, Inc.,… | Non Sterility; microbial contamination identified as Aspergillus species | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class III | September 3, 2014 | CareOne Nicotine Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter. Perrigo, 502… | Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of… | Perrigo Holland Inc | Terminated |
| Class II | September 3, 2014 | VIVITROL VIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial NDC… | Customer complaints for failure to deliver the dose. | Alkermes, Inc. | Terminated |
| Class II | August 27, 2014 | fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable bag,… | Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were… | Healix Infusion Therapy, Inc. | Terminated |
| Class II | August 27, 2014 | ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL) Single Use 5 mL Syringe, For IV,… | Labeling: Label Error on Declared Strength; The outer light protective bags, where the ephedrine sulfate injection… | US Compounding Inc | Terminated |
| Class III | August 27, 2014 | Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals… | Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities. | Mylan Pharmaceuticals Inc. | Terminated |
| Class II | August 27, 2014 | fentaNYL 2750 mcg/55 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG, For… | Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were… | Healix Infusion Therapy, Inc. | Terminated |
| Class III | August 27, 2014 | Triveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trigen… | Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 micrograms) on the… | Trigen Laboratories, Inc. | Terminated |
| Class II | August 27, 2014 | fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in flexable bag, COMPOUNDED… | Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were… | Healix Infusion Therapy, Inc. | Terminated |
| Class II | August 27, 2014 | fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chloride 100mL, in… | Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were… | Healix Infusion Therapy, Inc. | Terminated |
| Class II | August 27, 2014 | CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only,… | Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity. | Ben Venue Laboratories Inc | Terminated |
| Class I | August 27, 2014 | 0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, Baxter… | Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes | Baxter Healthcare Corp. | Terminated |