Drug product
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
D-0162-2023
Product summary
- Event
- Event 91441
- Status
- Terminated
- Classification
- Class III
- Quantity
- 10052 bottles
- Official record key
drug-enforcement:D-0162-2023
Official wording
Reason: Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Code information: Lot #: BLF2214A; Exp. 06/2025
Distribution pattern: Nationwide within United States and Puerto Rico.
Derived failure modes
-
Unknown
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.