DrugJun 7, 2023
Akorn Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle recall — FDA D-0855-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
June 2023 recalls — page 13
These records include useful source details for the selected month.
DrugJun 7, 2023
Akorn Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles recall — FDA D-0862-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL recall — FDA D-0856-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) recall — FDA D-0811-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles recall — FDA D-0793-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
SSM Health Care St. Louis DBA SSM St. Clare HYDROmorphone HCl 10 mg in 0.9% Sodium recall — FDA D-0776-2023
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or…
Class IIFDA: OngoingSSM Health Care St. Louis DBA SSM St. Clare Health…
DrugJun 7, 2023
Akorn Lactulose Solution, USP recall — FDA D-0815-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles recall — FDA D-0833-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles recall — FDA D-0826-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL recall — FDA D-0848-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles recall — FDA D-0810-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg) recall — FDA D-0807-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or recall — FDA D-0809-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray recall — FDA D-0791-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles recall — FDA D-0845-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes recall — FDA D-0824-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL recall — FDA D-0780-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Apraclonidine Ophthalmic Solution 0.5% recall — FDA D-0784-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free recall — FDA D-0808-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules recall — FDA D-0850-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles recall — FDA D-0854-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Prednisolone Oral Solution, USP, 15 mg/5 mL recall — FDA D-0836-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules recall — FDA D-0799-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Levofloxacin Oral Solution, 25 mg/mL recall — FDA D-0819-2023
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.