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 | June 14, 2023 | travoprost Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx only,… | Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container. | Golden State Medical Supply Inc. | Terminated |
| Class II | June 14, 2023 | Buprenorphine Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun… | CGMP Deviations | SUN PHARMACEUTICAL INDUSTRIES INC | Terminated |
| Class II | June 7, 2023 | Sodium Chloride Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius… | Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which… | Fresenius Medical Care Holdings, Inc. | Terminated |
| Class II | June 7, 2023 | Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by:… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by:… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akorn… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by:… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, Sterile,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Granisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials, Rx Only,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous Use Only, 2mL… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, Rx Only,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc.,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle.… | CGMP Deviations: Use of non-food grade lubricant in mixing vessel. | Denison Pharmaceuticals, LLC | Ongoing |
| Class II | June 7, 2023 | Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx Only, Distributed by:… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Operating… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intravenous Use Only,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distributed by: Akorn… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL)… | CGMP Deviations: Use of non-food grade lubricant in mixing vessel. | Denison Pharmaceuticals, LLC | Ongoing |
| Class II | June 7, 2023 | Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by: Akorn ,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL bottles,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP… | CGMP Deviations: Use of non-food grade lubricant in mixing vessel. | Denison Pharmaceuticals, LLC | Ongoing |
| Class II | June 7, 2023 | DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TECH… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, Sterile,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480 mL bottles,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine… | CGMP Deviations: Use of non-food grade lubricant in mixing vessel. | Denison Pharmaceuticals, LLC | Ongoing |
| Class II | June 7, 2023 | Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, Rx only, Distributed… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, Sterile,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules, Rx only,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM… | CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity,… | SSM Health Care St. Louis DBA SSM St. Clare Health Center | Ongoing |
| Class II | June 7, 2023 | Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30 mL bottles,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, b) 5mL… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Distributed by:… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count bottles,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, Rx… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured by: Akorn… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg),… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, Rx only,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL ampules, b) 2mL… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Tropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx only, Distributed by: Akorn… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5 g tubes, Rx… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Distributed… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Distributed by:… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by:… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use, 1… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, Rx… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, Distributed… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Only, Manufactured by:… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class III | June 7, 2023 | Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by:… | Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride | New England Life Care, Inc. dba Advanced Compounding Solutions | Terminated |
| Class II | June 7, 2023 | Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes, and c)… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed by: Akorn… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by:… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by:… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distributed by:… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, Distributed by: Akorn… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Distributed… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured by: Akorn,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a)… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Akorn Inc.,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by:… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Distributed… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a) 1 mL… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, Rx Only,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Only,… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manufactured by:… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class II | June 7, 2023 | Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH PHARMACAL… | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. | Ongoing |
| Class I | June 7, 2023 | G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough… | Product mix-up: incorrect product was found inside the G-Supress DX product carton. | Novis PR, LLC dba Kramer Novis | Terminated |
| Class II | May 31, 2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4.5%/Dextrose 10% with HEPARIN,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with CALCIUM and… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | oxyTOCIN 40 units added to 0.9% sodium chloride 1,000 bag, Rx only, Central Admixture… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Reperfusate No Potassium, packaged in 477.5 mL per bag, Rx only,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Maintenance 4:1 low potassium/low tromethamine, 36 mEq K, packaged… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | oxyTOCIN 30 units added to Lactated Ringer's 500 mL per bag, Rx only, Central Admixture… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | NORepinephrine added to 0.9% sodium chloride, 16 mg/250 mL* (64 mcg/mL), 250 mL per bag,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Microplegia Solution, HIGH POTASSIUM (100 mEq), packaged in 200 mL per bag, Rx only,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | vancomycin added to 0.9% sodium chloride, 750 mg/250 mL* (3 mg/mL), 250 mL per bag, Rx… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | NORepinephrine added to 0.9% sodium chloride, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Reperfusate 4:1 low potassium, 7.5 mEq K, packaged in 238.75 mL… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Modified St Thomas Solution, low potassium, HIGH SODIUM… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only,… | Sub-potent Drug | Revive Rx LLC dba Revive Rx Pharmacy | Ongoing |
| Class III | May 31, 2023 | Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular,… | Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual… | Amneal Pharmaceuticals of New York, LLC | Terminated |
| Class II | May 31, 2023 | FOAMING HAND SANITIZER, fresh mint scent, 62% alcohol, 1 Gallon / 3.78 Liters bottle, 290… | CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. | Alpha Aromatics | Terminated |
| Class II | May 31, 2023 | Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a… | Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found… | Aurobindo Pharma USA Inc. | Completed |
| Class II | May 31, 2023 | potassium phosphate 30 mmole added to 0.9% sodium chloride 500 mL per bag, Rx only,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | vancomycin added to 0.9% sodium chloride, 1.5 g/250 mL* (6 mg/mL), 250 mL per bag, Rx… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | EPINEPHrine added to dextrose 5%, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx only,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | vasopressin 40 units added to 0.9% sodium chloride 100 mL*, 0.4 units/mL*, 100 mL per… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | HyperLyte CR Injection, 500 mL bag, Rx only, Central Admixture Pharmacy Services, 6580… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | EPINEPHrine added to dextrose 5%, 2 mg/250 mL* (8 mcg/mL), 250 mL per bag, Rx only,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Modified St Thomas Solution, HIGH POTASSIUM, HIGH SODIUM… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 6%/Dextrose 10% with low calcium and… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10% with low calcium and… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | potassium phosphate 15 mmole added to 0.9% sodium chloride 250 mL per bag, Rx only,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Reperfusate No Potassium, packaged in 238.75 mL per bag, Rx only,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Neonatal PN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with low calcium and… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | dilTIAZem added to 0.9% sodium chloride, 125 mg/125 mL* (1 mg/mL), 125 mL per bag, Rx… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | PHENYLephrine added to 0.9% sodium chloride, 20 mg/250 mL* (80 mcg/mL), 250 mL per bag,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10%, packaged in 250 mL… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | NORepinephrine added to dextrose 5%, 16 mg/250 mL* (64 mcg/mL), 250 mL per bag, Rx only,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Maintenance 4:1 in Ringer's, low potassium, 12 mEq K, packaged in… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | EPINEPHrine added to 0.9% sodium chloride, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | norepinephrine 4 mg added to dextrose 5% 250 mL*, 16 mcg/mL, 250 mL per bag, Rx only,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | oxyTOCIN 20 units added to dextrose 5%/Lactated Ringer's 1,000 mL per bag, Rx only,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Modified St Thomas Formula, low potassium, 70 mEq K, packaged in… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | vancomycin added to dextrose 5%, 1.5 g/250 mL* (6 mg/mL), 250 mL per bag, Rx only,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with CALCIUM, packaged… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | oxyTOCIN 20 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Central… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | oxyTOCIN 20 units added to Lactated Ringer's 1,000 mL per bag, Rx only, Central Admixture… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL per bag, Rx only, Central… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10%, packaged in 250 mL… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | oxyTOCIN 30 units added to dextrose 5%/Lactated Ringer's 500 mL per bag, Rx only, Central… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | dilTIAZem added to dextrose 5%, 125 mg/125 mL* (1 mg/mL), 125 mL per bag, Rx only,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Potassium Acetate Injection, 2 mEq/mL, 500 ml bag, Rx only, Central Admixture Pharmacy… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | bupropion hydrochloride buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only,… | Failed Dissolution Specifications; during stability testing | SUN PHARMACEUTICAL INDUSTRIES INC | Terminated |
| Class II | May 31, 2023 | Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals,… | Lack of Assurance of Sterility | Sagent Pharmaceuticals Inc | Ongoing |
| Class II | May 31, 2023 | vasopressin 20 units added to 0.9% sodium chloride 100 mL*, 0.2 units/mL*, 100 mL per… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Maintenance 4:1 Plasma-Lyte/Tromethamine, low potassium, packaged… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | heparin added to 0.9% sodium chloride, 2,500 units/500 mL* (5 units/mL), 500 mL per bag,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Induction 4:1 High Potassium, 30 mEq K, packaged in 415 mL per… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Microplegia (MSA/MSG 0.92 Molar) packaged in 125 mL per bag, Rx only, Central Admixture… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | NORepinephrine added to 0.9% sodium chloride, 8 mg/250 mL* (32 mcg/mL), 250 mL per bag,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10% with CALCIUM and… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00;… | CGMP Deviations: recalling drug products following an FDA inspection. | Amerisource Health Services LLC | Terminated |
| Class II | May 31, 2023 | diphenhydrAMINE 25 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial Additive Bag,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | vancomycin added to 0.9% sodium chloride, 1.75 g/500 mL* (3.5 mg/mL), 500 mL per bag, Rx… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Induction 4:1, HIGH POTASSIUM/low tromethamine, 36 mEq K, packaged… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Sodium Phosphates Injection 4 mEq/3 mMol/mL, 500 ml bag, Rx only, Central Admixture… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, del Nido Formula, packaged in 1,052.8 mL per bag, Rx only, Central… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals,… | Lack of Assurance of Sterility | Sagent Pharmaceuticals Inc | Ongoing |
| Class II | May 31, 2023 | MSA 7.84% MSG 8.56% (0.92M) Comp. Sol. 1000 ml bag, Rx only, Central Admixture Pharmacy… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with low calcium and… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Induction 4:1, High Potassium, 60 mEq K, packaged in 830 mL per… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with CALCIUM, packaged… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4%/Dextrose 10%, packaged in 250 mL… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Reperfusate 4:1 low potassium, 15 mEq K, packaged in 477.5 mL per… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with low calcium and… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Maintenance 4:1 Plasmalyte, low potassium, low K, packaged in 1047… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4%/Dextrose 10% with CALCIUM and… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT… | Lack of Assurance of Sterility | Sagent Pharmaceuticals Inc | Ongoing |
| Class II | May 31, 2023 | vancomycin added to 0.9% sodium chloride, 2 g/500 mL* (4 mg/mL), 500 mL per bag, Rx only,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | heparin added to 0.9% sodium chloride, 2,500 units/250 mL* (10 units/mL), 250 mL per bag,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | HyperLyte CR Injection, 250 mL bag, Rx only, Central Admixture Pharmacy Services, 6580… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), 250 mL per bag,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Induction 4:1 Plasma-Lyte/Tromethamine, High Potassium, packaged… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | PHENYLephrine added to 0.9% sodium chloride, 10 mg/250 mL* (40 mcg/mL), 250 mL per bag,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Induction 8:1 High Potassium, 108 mEq K, packaged in 500 mL per… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | PHENYLephrine added to 0.9% sodium chloride, 25 mg/250 mL* (100 mcg/mL), 250 mL per bag,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | oxyTOCIN 60 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Central… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Induction 8:1 non-enriched, HIGH POTASSIUM, 70 mEq K, packaged in… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Modified del Nido Microplegia, packaged in 40 mL per syringe, Rx only, Central Admixture… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | phenylephrine 50 mg added to 0.9% sodium chloride 250 mL*, 200 mcg/mL*, 250 mL per bag,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Transplant Solution (Plasma-Lyte A), packaged in 165 mL per bag, Rx only, Central… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | vancomycin added to dextrose 5%, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Maintenance 8:1 low potassium, 24 mEq K, packaged in 500 mL per… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | vasopressin 50 units added to 0.9% sodium chloride 50 mL*, 1 unit/mL*, 50 mL in 100 mL… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | oxyTOCIN 10 units added to Lactated Ringer's 500 mL per bag, Rx only, Central Admixture… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | heparin added to 0.9% sodium chloride, 5,000 units/500 mL* (10 units/mL), 500 mL per bag,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | vancomycin added to 0.9% sodium chloride, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, LEESBURG CARDIOPLEGIA, packaged in 1030.2 mL per bag, Rx only,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with CALCIUM and… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Maintenance 8:1 non-enriched, low potassium, 24 mEq K, packaged in… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | heparin added to 0.9% sodium chloride, 4,000 units/1,000 mL* (4 units/mL), 1,000 mL per… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM and… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Lidocaine 2% HCl Inj, 500mL bag, Rx only, Central Admixture Pharmacy Services, 6580… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | EPINEPHrine added to dextrose 5%, 8 mg/250 mL* (32 mcg/mL), 250 mL per bag, Rx only,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Induction 4:1 Plasmalyte, HIGH POTASSIUM, HIGH K, packaged in 542… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Warm Induction 4:1 HIGH POTASSIUM/low tromethamine, 40 mEq K,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | tromethamine 0.3 Molar, 50 mL syringe, Rx only, Central Admixture Pharmacy Services,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | diphenhydrAMINE 50 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial Additive Bag,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | heparin added to 0.9% sodium chloride, 7,500 units/1,000 mL* (7.5 units/mL), 1000 mL per… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 6%/Dextrose 10% with CALCIUM and… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Induction 8:1 High Potassium/low dextrose, 100 mEq K, packaged in… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Microplegia Solution, MSA/MSG 0.92 Molar with CP2D, packaged in 120 mL per bag, Rx only,… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | vancomycin added to 0.9% sodium chloride, 1 g/250 mL* (4 mg/mL), 25 250 mL per bag, Rx… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Induction 4:1 in Ringer's, HIGH POTASSIUM, 48 mEq K, packaged in… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Modified St Thomas Formula, HIGH POTASSIUM, 122 mEq K, packaged in… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Reperfusate 4:1 low potassium/low tromethamine, 15 mEq K, packaged… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Warm Induction 4:1 High Potassium (40 mEq) packaged in 500 mL per… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | oxyTOCIN 15 units added to Lactated Ringer's 250 mL per bag, Rx only, Central Admixture… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Cardioplegia Solution, Maintenance 4:1 low potassium, 20 mEq K, packaged in 810 mL per… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | vancomycin added to 0.9% sodium chloride, 1.5 g/500 mL* (3 mg/mL), 500 mL per bag, Rx… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL per bag, Rx only, Central… | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to… | Central Admixture Pharmacy Services, Inc. | Terminated |
| Class II | May 31, 2023 | Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00;… | CGMP Deviations: recalling drug products following an FDA inspection. | Amerisource Health Services LLC | Terminated |
| Class II | May 31, 2023 | Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b)… | CGMP Deviations: recalling drug products following an FDA inspection. | Amerisource Health Services LLC | Terminated |
| Class III | May 31, 2023 | Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets… | Labeling: Incorrect or Missing Package Insert | Teva Pharmaceuticals USA Inc | Terminated |
| Class III | May 31, 2023 | Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets… | Labeling: Incorrect or Missing Package Insert | Teva Pharmaceuticals USA Inc | Terminated |
| Class III | May 31, 2023 | Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets… | Labeling: Incorrect or Missing Package Insert | Teva Pharmaceuticals USA Inc | Terminated |
| Class III | May 31, 2023 | Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets… | Labeling: Incorrect or Missing Package Insert | Teva Pharmaceuticals USA Inc | Terminated |
| Class III | May 31, 2023 | Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets… | Labeling: Incorrect or Missing Package Insert | Teva Pharmaceuticals USA Inc | Terminated |
| Class II | May 24, 2023 | Ampicillin for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only,… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Manufactured for: Xellia… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1… | CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity,… | RemedyRepack Inc. | Ongoing |
| Class II | May 24, 2023 | Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest… | CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity,… | RemedyRepack Inc. | Ongoing |
| Class II | May 24, 2023 | Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Mfg. for:… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for:… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care,… | Lack of Assurance of Sterility | Apollo Care, LLC | Ongoing |
| Class II | May 24, 2023 | VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care,… | Lack of Assurance of Sterility | Apollo Care, LLC | Ongoing |
| Class II | May 24, 2023 | LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest… | CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity,… | RemedyRepack Inc. | Terminated |
| Class II | May 24, 2023 | Lorazepam Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL… | Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during… | Hikma Pharmaceuticals USA Inc. | Terminated |
| Class II | May 24, 2023 | Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, Rx only, Mfd for… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Ceftriaxone for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care,… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Ceftriaxone for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Ampicillin and Sulbactam for Injection, USP 1.5 gram per vial, Rx only, Manufactured for:… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care,… | Lack of Assurance of Sterility | Apollo Care, LLC | Ongoing |
| Class II | May 24, 2023 | Ampicillin for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care,… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe, Solution… | Lack of Assurance of Sterility | Apollo Care, LLC | Ongoing |
| Class II | May 24, 2023 | Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only,… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only,… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only,… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfg. for: Piramal… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Ampicillin for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care,… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Succinylcholine Cl Injection, 100 mg per 5 mL (20 mg/mL), Single-Use Syringe, Rx only,… | Lack of Assurance of Sterility | Apollo Care, LLC | Ongoing |
| Class II | May 24, 2023 | FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe, Rx Only, Apollo Care, LLC, 3801… | Lack of Assurance of Sterility | Apollo Care, LLC | Ongoing |
| Class II | May 24, 2023 | Ketamine Injection, 50 mg per 5 mL (10 mg/mL), Single-Use Syringe, Rx only, Apollo Care,… | Lack of Assurance of Sterility | Apollo Care, LLC | Ongoing |
| Class II | May 24, 2023 | Ampicillin and Sulbactam for Injection, USP 3 grams vials, Rx only, Mfg. for: Piramal… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care,… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care,… | Lack of Assurance of Sterility | Apollo Care, LLC | Ongoing |