D-0162-2023 Class III Terminated
FDA drug recall D-0162-2023 was initiated by MACLEODS PHARMA USA, INC on January 5, 2023 and is designated Class III. Reason for recall: Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles. The recall status is terminated (terminated June 24, 2025). Affected quantity: 10052 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 25, 2023
- Initiation Date
- January 5, 2023
- Termination Date
- June 24, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10052 bottles
Product Description
Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540; Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-022-08
Reason for Recall
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Distribution Pattern
Nationwide within United States and Puerto Rico.
Code Information
Lot #: BLF2214A; Exp. 06/2025