Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Recalling firm

Macleods Pharma USA, INC

NDC code

33342-022-08

Origin

NJ, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0162-2023

Other Levofloxacin recalls

See all

Class II · Moderate risk Ongoing Apr 26, 2023

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

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

Akorn, Inc. D-0820-2023

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 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