U.S. Recalls in June 2023

June 2023 recalls — page 12

These records include useful source details for the selected month.

2023 archive →

DrugJun 7, 2023

Akorn Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous Use Only recall — FDA D-0828-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Granisetron HCl Injection, USP, 1 mg/mL recall — FDA D-0806-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

New England Life Care, Inc. dba Advanced Phenylephrine HCl 20 mg added to 0.9% Sodium recall — FDA D-0778-2023

Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride

Class IIIFDA: TerminatedNew England Life Care, Inc. dba Advanced Compounding…

DrugJun 7, 2023

Akorn Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles recall — FDA D-0832-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles recall — FDA D-0834-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles recall — FDA D-0835-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle recall — FDA D-0783-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn DOCU LIQUID recall — FDA D-0801-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Acetic Acid Otic Solution, 15 mL per bottle recall — FDA D-0781-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5 g tubes recall — FDA D-0831-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Tropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles recall — FDA D-0853-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton recall — FDA D-0777-2023

Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.

Class IIFDA: TerminatedFresenius Medical Care Holdings, Inc.

DrugJun 7, 2023

Akorn Sufenta recall — FDA D-0847-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Lactulose Solution, USP (Oral), 10g/15 mL recall — FDA D-0814-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles recall — FDA D-0796-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile recall — FDA D-0813-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles recall — FDA D-0852-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles recall — FDA D-0838-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles recall — FDA D-0839-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn DetomiSed (detomidine hydrochloride) recall — FDA D-0798-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles recall — FDA D-0829-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL recall — FDA D-0842-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL recall — FDA D-0837-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Rifampin Capsules USP, 150 mg, 30-count bottles recall — FDA D-0840-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

How to use this monthly recall archive

Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.

U.S. Recalls — June 2023

June 2023 recalls — page 12

How to use this monthly recall archive