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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 2361–2380 of 17,723 recalls

Class IIOngoing

Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Only, Manufactured by: Hi-Tech Pharmacal Co., INC., Amityville, NY 11701. ALL NDCs

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 mL bottles, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, Sterile, Rx Only, For Ophthalmic Use Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Akorn, Inc.

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

April 26, 2023 · DrugView details →

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