Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 560

The newest recall records with useful source details are listed here.

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.

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.

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

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