Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only…

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

Recalling firm

Actavis Inc

NDC code

50383-283-05

Origin

NJ, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0514-2017

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 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