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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
Most recent recall enforcement reports first.
Class Reported Product Reason Firm Status
Class I June 1, 2016 CLINIMIX E CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with… Presence of Particulate Matter: identified as dried skin. Baxter Healthcare Corp. Terminated
Class II May 25, 2016 Renovo Patch (Capsaicin, 0.0375%, Menthol, USP 5.00%), 3-count patches per carton, Rx… Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent. TMIG Inc Terminated
Class II May 25, 2016 BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. (355 ml)… Microbial Contamination of Non-Sterile Products: Failed S.aureus test. Keystone Laboratories Inc Terminated
Class III May 25, 2016 Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL… Failed pH Specifications: Confirmed high out of specification (OOS) results for pH. Hospira Inc. Ongoing
Class III May 25, 2016 col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item… Superpotent Drug: High out of specification results for assay at the 6 month time point interval. Allegiant Health Terminated
Class II May 18, 2016 Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad… cGMP Deviations; product does not comply with cGMP requirements Sesderma, SL Ongoing
Class II May 18, 2016 Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%)… cGMP Deviations; product does not comply with cGMP requirements Sesderma, SL Ongoing
Class II May 18, 2016 Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan… Failed Dissolution Specifications; three month stability time point. Mylan Pharmaceuticals Inc. Terminated
Class II May 18, 2016 Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL)… cGMP Deviations; product does not comply with cGMP requirements Sesderma, SL Ongoing
Class II May 18, 2016 Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's… Failed Impurities/Degradation Specifications; 12 month stability time point Dr. Reddy's Laboratories, Inc. Terminated
Class II May 18, 2016 Dryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL) bottle,… cGMP Deviations; product does not comply with cGMP requirements Sesderma, SL Ongoing
Class II May 18, 2016 Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 fl oz (75 mL) bottle, over… cGMP Deviations; product does not comply with cGMP requirements Sesderma, SL Ongoing
Class II May 18, 2016 Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%)… cGMP Deviations; product does not comply with cGMP requirements Sesderma, SL Ongoing
Class II May 18, 2016 Dryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bottle, over… cGMP Deviations; product does not comply with cGMP requirements Sesderma, SL Ongoing
Class II May 18, 2016 Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF 50 Light,… cGMP Deviations; product does not comply with cGMP requirements Sesderma, SL Ongoing
Class II May 18, 2016 Screenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 50, Brown,… cGMP Deviations; product does not comply with cGMP requirements Sesderma, SL Ongoing
Class II May 18, 2016 Repaskin 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, Broad… cGMP Deviations; product does not comply with cGMP requirements Sesderma, SL Ongoing
Class II May 18, 2016 BREVIBLOC Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride,… Discoloration: presence of atypical yellow discoloration of the solution . Baxter Healthcare Corp. Terminated
Class II May 11, 2016 Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% /… Presence of Particulate Matter Akorn, Inc. Terminated
Class III May 11, 2016 Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bottle, Rx… Labeling: Not elsewhere classified - count on the label was incorrect. A-S Medication Solutions LLC. Terminated
Class III May 11, 2016 Venlafaxine Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC… Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging,… Bryant Ranch Prepack Inc. Terminated
Class II May 11, 2016 Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-01), shrink-… Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not… VistaPharm, Inc. Terminated
Class III May 11, 2016 Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL… Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or… Hospira Inc. Ongoing
Class III May 4, 2016 SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC,… Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets. Mckesson Packaging Services Terminated
Class III April 27, 2016 Zemplar Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie Inc.… Failed Content Uniformity Specifications AbbVie Inc. Terminated
Class II April 27, 2016 Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and… Failed Impurities/Degradation Specifications Impax Laboratories, Inc. Terminated
Class II April 27, 2016 Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and… Failed Impurities/Degradation Specifications Impax Laboratories, Inc. Terminated
Class II April 27, 2016 Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc.,… Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin. Hospira Inc. Terminated
Class II April 27, 2016 Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx only, Hospira,… Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin. Hospira Inc. Terminated
Class II April 27, 2016 Dextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc.,… Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin. Hospira Inc. Terminated
Class II April 27, 2016 Dextrose Injection, USP, 70%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc.,… Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin. Hospira Inc. Terminated
Class II April 27, 2016 Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, Inc., Lake… Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin. Hospira Inc. Terminated
Class II April 27, 2016 Dextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Hospira, Inc.,… Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin. Hospira Inc. Terminated
Class III April 27, 2016 Telmisartan Tablets, USP, 80 mg, 30-count (3 x 10 unit-dose blisters) per carton, Rx… Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the… Torrent Pharmaceuticals Limited Terminated
Class III April 20, 2016 Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs per… Labeling: Incorrect or Missing Lot and/or Exp Date Amerisource Health Services Terminated
Class III April 20, 2016 Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs per carton,… Labeling: Incorrect or Missing Lot and/or Exp Date Amerisource Health Services Terminated
Class III April 20, 2016 Haloperidol Decanoate Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC,… Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result. Fresenius Kabi USA, LLC Terminated
Class III April 20, 2016 Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax… Labeling: Incorrect or Missing Lot and/or Exp. Date Impax Laboratories, Inc. Terminated
Class III April 20, 2016 Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax… Labeling: Incorrect or Missing Lot and/or Exp. Date Impax Laboratories, Inc. Terminated
Class III April 20, 2016 Simvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 count… Subpotent Drug Biocon Inc Terminated
Class II April 20, 2016 Cisatracurium Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous… Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the… Fresenius Kabi USA, LLC Terminated
Class II April 13, 2016 Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc.,… Lack of Assurance of Sterility: incomplete or missing data regarding production. Meditech Laboratories, Inc Terminated
Class II April 13, 2016 Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL… Lack of Assurance of Sterility: incomplete or missing data regarding production. Meditech Laboratories, Inc Terminated
Class III April 13, 2016 Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only.… Failed Dissolution Specifications Purdue Pharma L.P. Terminated
Class II April 13, 2016 Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL… Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use… Meditech Laboratories, Inc Terminated
Class II April 13, 2016 Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 mcg/mL)… Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use… Meditech Laboratories, Inc Terminated
Class III April 13, 2016 Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle,… Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine… Bio-pharm, Inc. Terminated
Class III April 13, 2016 Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters… Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect lot number… Apace KY LLC Terminated
Class II April 13, 2016 Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection,… Superpotent Drug: one ingredient was found to be above assay specification. Meditech Laboratories, Inc Terminated
Class II April 13, 2016 Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 mcg/mL)… Lack of Assurance of Sterility: incomplete or missing data regarding production. Meditech Laboratories, Inc Terminated
Class II April 13, 2016 Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL)… Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use… Meditech Laboratories, Inc Terminated
Class II April 13, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and… Failed Impurities/Degradation Specifications: Out of specification for impurities. Actavis Elizabeth LLC Terminated
Class II April 13, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and… Failed Impurities/Degradation Specifications: Out of specification for impurities. Actavis Elizabeth LLC Terminated
Class III April 13, 2016 VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement,… Defective Delivery System: Product may contain leaking capsules. Virtus Pharmaceuticals, Llc Terminated
Class II April 13, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and… Failed Impurities/Degradation Specifications: Out of specification for impurities. Actavis Elizabeth LLC Terminated
Class II April 13, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and… Failed Impurities/Degradation Specifications: Out of specification for impurities. Actavis Elizabeth LLC Terminated
Class III April 13, 2016 SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant… Labeling: Label Error on Declared Strength Jubilant Draximage Inc Terminated
Class II April 6, 2016 Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only,… Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial Dr. Reddy's Laboratories, Inc. Terminated
Class II April 6, 2016 Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL… Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml. Safecor Health, LLC Terminated
Class II April 6, 2016 Tobramycin 14 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th… Lack of Assurance of Sterility Walter's Pharmacy Terminated
Class II April 6, 2016 Atropine 0.01% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy 401 N 17th St… Lack of Assurance of Sterility Walter's Pharmacy Terminated
Class III April 6, 2016 UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribution, Inc.… CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air. Praxair Inc. Terminated
Class II April 6, 2016 Vancomycin 25mg/mL Solution, 10 mL bottles, Rx only, Walter's Pharmacy 401 N 17th St.,… Lack of Assurance of Sterility Walter's Pharmacy Terminated
Class II April 6, 2016 Edetate Disodium 2% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy, 401 N 17th… Lack of Assurance of Sterility Walter's Pharmacy Terminated
Class II April 6, 2016 Vancomycin 50mg/mL Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St,… Lack of Assurance of Sterility Walter's Pharmacy Terminated
Class II April 6, 2016 Acetylcysteine 10% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy 401 N 17th St,… Lack of Assurance of Sterility Walter's Pharmacy Terminated
Class II April 6, 2016 Tobramycin 15mg/mL Ophth Solution, packaged in 5mL and 10mL bottles, Rx only, Walter's… Lack of Assurance of Sterility Walter's Pharmacy Terminated
Class II April 6, 2016 Cefazolin 50 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th… Lack of Assurance of Sterility Walter's Pharmacy Terminated
Class II April 6, 2016 Edetate Disodium 3% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th… Lack of Assurance of Sterility Walter's Pharmacy Terminated
Class III April 6, 2016 UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution, Inc.… CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air. Praxair Inc. Terminated
Class II April 6, 2016 Silver Nitrate 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St.,… Lack of Assurance of Sterility Walter's Pharmacy Terminated
Class II April 6, 2016 Lidocaine Nebulizer 1% Solution, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA… Lack of Assurance of Sterility Walter's Pharmacy Terminated
Class II April 6, 2016 Rose Bengal 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St.,… Lack of Assurance of Sterility Walter's Pharmacy Terminated
Class III April 6, 2016 Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle (237 mL),… Labeling: Label Mix-Up Pfizer Inc Terminated
Class II April 6, 2016 Lidocaine Nebulizer 2% Solution, packaged in 50mL, 100mL, 120mL, and 150mL bottles, Rx… Lack of Assurance of Sterility Walter's Pharmacy Terminated
Class III April 6, 2016 Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only,… Labeling: Incorrect or Missing Lot and/or Exp Date Genzyme Corporation Terminated
Class II March 30, 2016 Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose… Cross contamination with other products: metronidazole Sagent Pharmaceuticals Inc Terminated
Class II March 30, 2016 Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, Independence,… cGMP Deviations; trailer may not have met GMP requirements prior to filling AGA Gas Inc Terminated
Class II March 30, 2016 Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60… Defective Delivery System: Some units have actuation counters set to a number other than 60. AstraZeneca Pharmaceuticals LP Terminated
Class III March 23, 2016 Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement, Rx, 100… Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could contain tablets… Virtus Pharmaceuticals, Llc Terminated
Class III March 23, 2016 NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd.,… Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles. Teva Pharmaceuticals USA Terminated
Class III March 23, 2016 NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride… Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration Pharmedium Services, LLC Terminated
Class II March 23, 2016 Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By:… Failed Impurities/Degradation Specifications: Out of specification test results for impurities during stability testing. Teva Pharmaceuticals USA Terminated
Class III March 23, 2016 Oxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders), Packaged in a)… CGMP Deviations: Cylinders filled using out of date gauges. Medical Park Homecare, Inc Terminated
Class III March 23, 2016 NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride… Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration Pharmedium Services, LLC Terminated
Class III March 16, 2016 Scrub-Stat Scrub-Stat 4 (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in a) 800 mL… Subpotent drug Ecolab Inc Terminated
Class II March 16, 2016 Morphine Sulfate 20 mg/ml/Bupivacaine HCL 11.3 mg/ml, vol. 40 ml syringe, Rx only,… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class II March 16, 2016 Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 30 mg/ml, vol. 20 ml syringe, Rx only, Hartley… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class II March 16, 2016 Baclofen 2000 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach,… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class I March 16, 2016 Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA, UPC… Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine. Tf Supplements Terminated
Class II March 16, 2016 Hydromorphone HCL 20 mg/ml/Bupivacaine HCL 40 mg/ml, vol. 20 ml syringe Rx only, Hartley… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class II March 16, 2016 Morphine Sulfate 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class II March 16, 2016 Morphine Sulfate 0.6 mg/ml, vol. 200 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class II March 16, 2016 Morphine Sulfate 1.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class II March 16, 2016 Hydromorphone 12 mg/ml/Baclofen 450 mcg/ml, vol. 20 ml, syringe, Rx only, Hartley Med Ctr… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class II March 16, 2016 Morphine Sulfate 9 mg/ml/Sufentanil Cit 180 mcg/ml/Bupivacaine HCL 33 mg/ml, vol. 20 ml… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class III March 16, 2016 Atorvastatin Calcium 20 mg, 10 tablets per blister,100-count package, Rx Only… Failed Impurities/Degradation Specifications Golden State Medical Supply Inc. Terminated
Class II March 16, 2016 Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 20 ml syringe, Rx only, Hartley… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class II March 16, 2016 Hydromorphone HCL 7 mg/ml/Bupivacaine HCL 11.2 mg/ml, vol. 40 ml syringe, Rx only,… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class II March 16, 2016 Hydromorphone HCL 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class II March 16, 2016 Sufentanil Cit 200 mcg/ml/Clonidine HCL 1600 mcg/ml, vol. 42 ml syringe, Rx only, Hartley… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class II March 16, 2016 Hydromorphone HCL 10 mg/ml/Baclofen 460 mcg/ml/Bupivacaine HCL, vol. 40 ml syringe, Rx… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class II March 16, 2016 Morphine Sulfate 11 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class II March 16, 2016 Morphine Sulfate 0.5 mg/ml/Baclofen 1000 mcg/ml/, vol. 20 ml syringe, Rx only, Hartley… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class II March 16, 2016 Hydromorphone HCL 10 mg/ml/Fentanyl Citrate 0.15 mg/ml, vol. 40 ml syringe, Rx only,… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class II March 16, 2016 Baclofen 5000 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach,… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class II March 16, 2016 Sufentanil Cit 1000 mcg/ml/Baclofen 300 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class II March 16, 2016 Hydromorphone HCL 25 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 40 ml syringe, Rx only, Hartley… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class II March 16, 2016 Hydromorphone HCL 10 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class II March 16, 2016 Hydromorphone HCL 2 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy Long… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class II March 16, 2016 Sufentanil Cit 50 mcg/ml/Clonidine HCL 1 mcg/ml/Bupivacaine HCL 5 mg/ml, vol. 20 ml… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class II March 16, 2016 Hydromorphone HCL 25 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class II March 16, 2016 Morphine Sulfate 10 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class II March 16, 2016 Morphine Sulfate 50 mg/ml/Bupivacaine HCL 24 mg/ml, vol. 20 ml syringe, Rx only, Hartley… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class I March 16, 2016 RHINO 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine. Tf Supplements Terminated
Class III March 16, 2016 Atorvastatin Calcium 40 mg, 10 tablets per blister,100-count package, Rx Only… Failed Impurities/Degradation Specifications Golden State Medical Supply Inc. Terminated
Class III March 16, 2016 Atorvastatin Calcium 10 mg, 10 tablets per blister,100-count package, Rx Only… Failed Impurities/Degradation Specifications Golden State Medical Supply Inc. Terminated
Class II March 16, 2016 Fentanyl Citrate 1.275 mg/ml/Baclofen 150 mcg/ml/Bupivacaine HCL 20 mg/ml/ Clonidine HCL… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class III March 16, 2016 Atorvastatin Calcium 80 mg, 10 tablets per blister,100-count package, Rx Only… Failed Impurities/Degradation Specifications Golden State Medical Supply Inc. Terminated
Class II March 16, 2016 Morphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml, vol. 22 ml syringe, Rx only, Hartley… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class II March 16, 2016 Morphine Sulfate 20 mg/ml, vol. 42 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class II March 16, 2016 Hydromorphone HCL 1 mg/ml, vol. 22 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long… Lack of Assurance of Sterility Hartley Medical Center Pharmacy, Incorporated Terminated
Class II March 9, 2016 Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For… Presence of Particulate Matter: Glass particles found in the product after reconstitution. Genzyme Corporation Terminated
Class II March 9, 2016 Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For… Presence of Particulate Matter: Glass particles found in the product after reconstitution. Genzyme Corporation Terminated
Class II March 9, 2016 Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, Texas 75023 Lack of assurance of sterility TexasStar Pharmacy Terminated
Class III March 9, 2016 sulfur8 medicated LIGHT FORMULA (sulfur) anti-dandruff hair & scalp conditioner, 2%,… Subpotent Drug: failed at the 3 and 6 month stability time points. J. Strickland and Co Terminated
Class II March 9, 2016 Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only,… Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit… Sun Pharma Global Fze Terminated
Class II March 9, 2016 Capecitabine Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle,… Failed Dissolution Specifications: low test results at the 18 month time-point Teva North America Terminated
Class II March 9, 2016 Sodium Chloride 0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare… PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect. Baxter Healthcare Corp. Terminated
Class III March 2, 2016 Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP,… Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed… Hospira Inc. Ongoing
Class II March 2, 2016 Medicated Better Braids, La Laque (salicylic acid) Spray, 2%,12 Fl. OZ. (355 ml.) bottle,… Microbial Contamination of a Non-Sterile Products: The product had a positive Staphylococcus aureus test result. Keystone Laboratories Inc Terminated
Class III March 2, 2016 Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial for… Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrect "Compounded" date,… Isomeric Pharmacy Solution, LLC Terminated
Class III March 2, 2016 risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by:… Failed Impurities/Degradation Specifications: Out of specification for a known degradant. Zydus Pharmaceuticals USA Inc Terminated
Class I February 24, 2016 Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl… Premiere Sales Group Terminated
Class I February 24, 2016 Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit… Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be tainted with undeclared… Fit Firm and Fabulous Terminated
Class II February 24, 2016 papaverine phentolamine prostaglandin; 30/1.5 mg/40 mcg/mL; 5 mL unit size, refrigerate,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 papaverine phentolamine prostaglandin; 35/1.2 mg/20 mcg/mL; 10 mL unit size, refrigerate,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 papaverine phentolamine prostaglandin; 12/1 mg/30 mcg/mL; 10 mL unit size, refrigerate,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 Folic Acid, 5 mg/mL, 30 mL unit size, refrigerate, This Rx is Compounded, Abbott's… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 papaverine phentolamine prostaglandin; 35/2.5 mg/1 mcg/mL, 10 mL, unit size, refrigerate,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 papaverine phentolamine prostaglandin; 17.16/0.57 mg/19.45 mcg/mL; 5 mLunit size,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 papaverine phentolamine prostaglandin; 25/0.83 mg/20 mcg/mL; 5 mL and 10 mL unit sizes,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 Insulin, 70/30, 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 papaverine phentolamine prostaglandin; 30/2 mg/25 mcg/mL; 5 mL unit size, refrigerate,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 papaverine phent, 25 mg/0.833 mg/mL, 20 mL unit size Refrigerate, This Rx is Compounded,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 hydroxyprogesterone w/ pres; 1 mg/mL, 20 mL unit size, refrigerate, This Rx is… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 papaverine phentolamine prostaglandin; 22.5/0.83 mg/8.3 mcg/mL; 5 mL and 10 mL unit… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 papaverine phentolamine prostaglandin; 30/2 mg/20 mcg/mL; 5 mL and 10 mL unit sizes,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 papaverine prostaglandin 30 mg/30 mcg/mL, 5 mL unit size, refrigerate, This Rx is… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 Bupivacaine, 0.25%, 450 mL, This Rx is Compounded, Abbott's Compounding Pharmacy,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class I February 24, 2016 Rhino 7 Platinum 3000, Single Blister Packs, distributed By Rhino 7, Made in USA Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl… MSNV, Inc dba National Video Supply Terminated
Class II February 24, 2016 papaverine phentolamine prostaglandin; 35/1.5 mg/50 mcg/mL, 5 mL unit size, refrigerate,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class I February 24, 2016 fentaNYL Citrate, Preservative Free, 5 mcg per mL In 0.9% Sodium Chloride, 1 mL Total… Subpotent Drug Pharmedium Services, LLC Terminated
Class II February 24, 2016 Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl Salicylate… Marketed without an approved NDA/ANDA Bonita Pharmaceuticals, LLC Terminated
Class I February 24, 2016 APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by:… Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted… Nuway Distributors, LLC Ongoing
Class II February 24, 2016 papaverine phentolamine prostaglandin; 30 mg/0.25 mg/10 mcg/mL; 10 mL unit size,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 papaverine phentolamine 30 mg/1mg/mL, 5 mL and 10 mL unit size, refrigerate, This Rx is… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 methylcobalamine 1 mg/mL, 1 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 Folic Acid, 10 mg/mL, 6 mL unit size, refrigerate, This Rx is Compounded, Abbott's… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 papaverine phentolamine prostaglandin; 18/0.6 mg/6 mcg/mL; 10 mL unit size, refrigerate,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 testosterone cypionate, 200 mg/mL, 6 mL and 10 mL unit sizes, This Rx is Compounded,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 progesterone/testosterone (ss oil) 0.25/20 mg/mL, 10 mL unit size, room temperature, This… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 calcium elemental, 3 mg/10 mL, 200 mL unit: This Rx is Compounded, Abbott's Compounding… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 papaverine phentolamine prostaglandin; 12/0.83 mg/10 mcg/ml; 5 mL and 10 mL unit size;… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 methylcobalamine 10 mg/mL, 10 mL and 12 mL unit sizes, refrigerate, This Rx is… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class I February 24, 2016 Rhino 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl… Premiere Sales Group Terminated
Class II February 24, 2016 testosterone cypionate, 100 mg/mL, 10 mL unit size, This Rx is Compounded, Abbott's… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 papaverine phentolamine, 35 mg/2.5 mg/mL; 5 mL unit size; refrigerate,This Rx is… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 papaverine phentolamine prostaglandin; 12/1 mg/9 mcg/mL; 5 mL and 10 mL unit sizes,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 papaverine phentolamine prostaglandin; 35/2 mg/40 mcg/mL, 10 mL unit size, refrigerate,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class I February 24, 2016 NATUREAL BURN FAT NATURE, 30-count capsules, packaged in clear plastic bottle,… Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine. Inaffit, LLC Terminated
Class II February 24, 2016 papaverine phentolamine prostaglandin; 22.5/0.83 mg/15 mcg/mL; 5 mL unit size,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class I February 24, 2016 CITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals or… Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrulline, and results… Medisca Inc Terminated
Class II February 24, 2016 TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0.3%,… Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the… Alcon Research, Ltd. Terminated
Class II February 24, 2016 papaverine phentolamine prostaglandin; 30/1 mg/10 mcg/mL; 5 mL, 7 mL and 10 mL unit… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 hydroxyprogesterone in sesame 250 mg/mL, 2 mL, 5 mL, 6 mL, 8 mL unit sizes, This Rx is… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class I February 24, 2016 Vitamin Supplement (Vial) D3, (cholecalciferol (vit D3)/lipoic acid/ubiquinol/… Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol). Glades Drugs Inc. Ongoing
Class II February 24, 2016 Estradiol cypionate/Test cyprionate; 2 mg/50 mg/ml, unit size 5 mL, This Rx is… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class I February 24, 2016 Akttive High Performance Fat Burner Gold dietary supplement capsules, 30-count bottle,… Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and… Life and More LLC Ongoing
Class II February 24, 2016 Hydroxycobalamine 30 mg/mL, 90 mL unit size, refrigerate, This Rx is Compounded, Abbott's… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 papaverine phentolamine prostaglandin; 25/1 mg/30 mcg/mL; 10 mL unit size, refrigerate,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 papaverine phentolamine prostaglandin; 25/1.5 mg/15 mcg/mL; 10 mL unit size, refrigerate,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 papaverine prostaglandin 30 mg/20 mcg/mL, 10 mL unit size; refrigerate, This Rx is… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class I February 24, 2016 fentaNYL Citrate, Preservative Free, 10 mcg per 1 mL In 0.9% Sodium Chloride, 1 mL Total… Subpotent Drug Pharmedium Services, LLC Terminated
Class II February 24, 2016 papaverine phentolamine prostaglandin; 30/1 mg/20 mcg/mL; 5 mL unit size, refrigerate,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 methylcobalamine 4 mg/mL, 5 mL and 30 mL unit sizes, refrigerate, This Rx is Compounded,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 papaverine phentolamine prostaglandin; 12/1 mg/10 mcg/mL 5 mL and 10 mL unit sizes,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class I February 24, 2016 Rhino 7 3000, 6 count bottles, Distributed by Rhino 7, Made in USA. Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl… MSNV, Inc dba National Video Supply Terminated
Class II February 24, 2016 papaverine phentolamine prostaglandin; 9/1 mg/10 mcg/mL, 10 mL, unit size, refrigerate,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class II February 24, 2016 papaverine phentolamine prostaglandin; 25/0.83 mg/10 mcg/mL; 10 mL unit size,… Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA… Abbott's Compounding Pharmacy, Inc. Terminated
Class III February 24, 2016 Paricalcitol Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's… Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules. Dr. Reddy's Laboratories, Inc. Terminated
Class III February 24, 2016 Paricalcitol Paricalcitol Capsules, 2 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's… Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules. Dr. Reddy's Laboratories, Inc. Terminated
Class III February 24, 2016 Paricalcitol Paricalcitol Capsules, 4 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's… Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules. Dr. Reddy's Laboratories, Inc. Terminated
Class I February 24, 2016 ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottle,… Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325… Medline Industries Inc Terminated
Class I February 24, 2016 ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle, Distributed… Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325… Medline Industries Inc Terminated
Class I February 24, 2016 MAGNESIUM SULFATE IN WATER Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g Total, 50 mL… Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin… Hospira Inc. Terminated
Class III February 17, 2016 Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed… Failed Impurities/Degradation Specifications; 9 month stability (manufacturer) Amerisource Health Services Terminated
Class III February 17, 2016 Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count… Failed Impurities/Degradation Specifications; 9 month stability timepoint Sandoz Inc Terminated
Class II February 17, 2016 SyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-free… Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the… Fagron, Inc Terminated
Class II February 17, 2016 SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially… Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the… Fagron, Inc Terminated
Class I February 17, 2016 Morphine Sulfate, 2 mg per mL (60 mg per 30 mL) 30 mL total volume in a 35 mL Monoject… Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay. Pharmedium Services, LLC Terminated
Class II February 17, 2016 SyrSpend SF, Suspending Base, a convenient, sweetened, sugar-free syrup-suspending… Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the… Fagron, Inc Terminated
Class II February 17, 2016 Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one… Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard… Safecor Health, LLC Terminated
Class II February 17, 2016 Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL amber bottle, Rx Only,… Defective Container: Confirmed customer complaints of leaking bottles. Safecor Health, LLC Terminated
Class II February 17, 2016 Pramipexole Dihydrochloride Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for:… Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet. Macleods Pharma Usa Inc Terminated
Class II February 10, 2016 Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo,… Labeling: label error on declared strength. Perrigo Company PLC Terminated
Class II February 10, 2016 Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perrigo,… Labeling: label error on declared strength. Perrigo Company PLC Terminated
Class III February 10, 2016 Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan… Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint. Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Terminated
Class II February 10, 2016 Lyrica Lyrica (pregabalin) capsules, 50 mg, 90-count bottle, Rx only, Distributed by:… FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential… Pfizer Inc. Terminated
Class II February 10, 2016 Lyrica Lyrica (pregabalin) capsules, 75 mg, 90-count bottle, Rx only, Distributed by:… FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential… Pfizer Inc. Terminated
Class II February 3, 2016 Levofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister cards per… Failed Dissolution Specifications: Unexplained low out of specification results for dissolution. Amerisource Health Services Terminated
Class III February 3, 2016 Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles… Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert. Bausch & Lomb, Inc. Terminated
Class II February 3, 2016 Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in 100ML Homepumps,… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 Invanz (ertapenem) Injection Recon Soln in NS, Packaged as a) 500MG in 50ML Homepumps and… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total… Stability data does not support expiry. Pharmakon Pharmaceuticals Terminated
Class II February 3, 2016 PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML Homepumps,… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 Nafcillin 2GM in NS, Packaged in 50ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX,… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 mL Syr,… Stability data does not support expiry. Pharmakon Pharmaceuticals Terminated
Class II February 3, 2016 ZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3.375GM in 50ML Homepumps, b) 4.5GM… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals,… Stability data does not support expiry. Pharmakon Pharmaceuticals Terminated
Class II February 3, 2016 GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, and c)… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class III February 3, 2016 Tropicamide Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and… Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert. Bausch & Lomb, Inc. Terminated
Class II February 3, 2016 Morphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes,… Stability data does not support expiry. Pharmakon Pharmaceuticals Terminated
Class II February 3, 2016 FLUCONAZOLE IN NACL 400MG in NS, Packaged in 200ML Homepumps, Rx Only. SENTARA HOME… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx only,… Stability data does not support expiry. Pharmakon Pharmaceuticals Terminated
Class II February 3, 2016 Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total… Subpotent drug. Pharmakon Pharmaceuticals Terminated
Class II February 3, 2016 GANCICLOVIR in NS, Packaged as a) 320MG in 64ML Homepumps and b) 2440MG in 488ML… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML Homepumps, c)… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 mL Syr,… Stability data does not support expiry. Pharmakon Pharmaceuticals Terminated
Class II February 3, 2016 Morphine Sulfate (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes,… Stability data does not support expiry. Pharmakon Pharmaceuticals Terminated
Class II February 3, 2016 Cancidas (caspofungin acetate) 58.4MG in NS, Packaged in 116.8ML Homepumps, Rx Only.… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.25 mg/mL, 3 mL in 5 mL Syr,… Stability data does not support expiry. Pharmakon Pharmaceuticals Terminated
Class II February 3, 2016 Midazolam 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 2… Stability data does not support expiry. Pharmakon Pharmaceuticals Terminated
Class II February 3, 2016 MORPHINE 10MG/ML in NS, Packaged in a) 150ML Homepumps and b) 250ML Homepumps, Rx Only.… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 HYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML Syringes, b) 150MG in 75ML Homepumps, c)… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 CEFAZOLIN, Packaged as a) 625MG in 6.2ML Syringes, b) 2GM in 20ML Syringes, c) 1GM in… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 SOD CHLORIDE (Sodium Chloride), Packaged in a) 0.9% in 30ML Homepumps, b) 0.9% 218ML… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total… Stability data does not support expiry. Pharmakon Pharmaceuticals Terminated
Class II February 3, 2016 Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML Homepumps,… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 CEFTRIAXONE in NS, Packaged as a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 1 mg/mL, 3 mL in 5 mL Syr,… Stability data does not support expiry. Pharmakon Pharmaceuticals Terminated
Class II February 3, 2016 ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only. SENTARA HOME HEALTH… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 Lactated Ringers, Packaged in a) 1500ML Homepumps, b) 2800ML Homepumps, and c) 3600ML… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 DOBUTAMINE HCL in D5W, Packaged as a) 240MG in 60ML Homepumps and b) 1520MG in 380ML… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 MEROPENEM in NS, Packaged as a) 1000MG in 250ML Homepumps, and b) 2GM in 100ML Homepumps,… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 ONDANSETRON HCL 8MG, Packaged in 100ML Homepumps. Rx Only. SENTARA HOME HEALTH SENTARA… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 SOLUMEDROL (methylprednisolone succinate) 1GM in NS, Packaged in 100ML Homepumps, Rx… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps, c) 1800ML… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated