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

FDA recall notice · announced January 25, 2023 · Macleods Pharma

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Reason for recall

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

Notes

Distribution: Nationwide within United States and Puerto Rico.
Lot/code information: Lot #: BLF2214A; Exp. 06/2025
Quantity: 10052 bottles
Status: Terminated
Products in this recall event:
- 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, I (D-0162-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.