DrugJun 7, 2023
Akorn Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles recall — FDA D-0861-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
June 2023 recalls — page 14
These records include useful source details for the selected month.
DrugJun 7, 2023
Akorn Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles recall — FDA D-0857-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn IC-Green recall — FDA D-0812-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles recall — FDA D-0797-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use recall — FDA D-0830-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
G-Supress DX recall — FDA D-0868-2023
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Class IFDA: TerminatedNovis PR, LLC dba Kramer Novis
DrugJun 7, 2023
Akorn Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials recall — FDA D-0825-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn AK-POLY-BAC recall — FDA D-0788-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye recall — FDA D-0779-2023
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, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial recall — FDA D-0863-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous recall — FDA D-0802-2023
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, 300 mg recall — FDA D-0841-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes recall — FDA D-0795-2023
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, 0.2%, 5mL bottles recall — FDA D-0860-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only recall — FDA D-0785-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Ferrous Sulfate Iron Supplement Drops recall — FDA D-0803-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles recall — FDA D-0827-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes recall — FDA D-0821-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes recall — FDA D-0786-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles recall — FDA D-0792-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray recall — FDA D-0787-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Denison Pharmaceuticals Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm recall — FDA D-0774-2023
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class IIFDA: OngoingDenison Pharmaceuticals, LLC
DrugJun 7, 2023
Akorn Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles recall — FDA D-0864-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Clobetasol Propionate Cream, USP, 0.05% recall — FDA D-0794-2023
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.