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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 2421–2440 of 17,723 recalls

Class IIOngoing

Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 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

DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, 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

Proparacaine HCl Ophthalmic Solution, USP 0.5%, 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

Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 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

Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, Rx only, Distributed by: VersaPharm, Inc. - An Akorn Company- 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

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 mL, and c)10 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

Clobetasol Propionate Shampoo, 0.05%, 4oz (118 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

Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30 mL bottles, c) 473 mL bottles, and d) 946 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

Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL ampules, b) 2mL ampules, c) 5mL ampules, For Intravenous and Epidural Use, 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

Acyclovir Oral Suspension, 200mg/5mL, 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

Tropicamide Ophthalmic Solution, USP 0.5%, 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

Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5 g tubes, 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

Acetic Acid Otic Solution, 15 mL per bottle, 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

DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, 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 IICompleted

Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Apotex Corp., Toronto, Ontario, Canada, M9L 1T9, NDC 60505-0823-6

Apotex Corp.

Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.

April 26, 2023 · DrugView details →

Class IIOngoing

Calcitriol Injection 2 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

Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, 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

Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, Sterile, 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

Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 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

Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured 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 →

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