Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

Akorn, Inc.

Origin

IL, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0820-2023

Other Levofloxacin recalls

See all

Class II · Moderate risk Ongoing Apr 26, 2023

Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles, and c) 480 mL bottles, Rx Only…

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

Akorn, Inc. D-0819-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials, Rx Only…

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

Akorn, Inc. D-0818-2023

Class III · Low risk Terminated Jan 5, 2023

Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540…

Reason Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.

Macleods Pharma USA, INC NDC 33342-022-08 D-0162-2023

Class II · Moderate risk Ongoing Oct 13, 2022

Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC…

Reason CGMP Deviations:

Akorn, Inc. D-0142-2023

Class II · Moderate risk Terminated Apr 13, 2022

Levofloxacin Tablets, 500 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6352-61

Reason cGMP deviations: Temperature abuse

Mckesson Medical-Surgical Inc. Corporate Office NDC 0904-6352-61 D-1088-2022