Recalls / Class III
Class IIID-0162-2023
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
- Affected lot / code info
- Lot #: BLF2214A; Exp. 06/2025
Why it was recalled
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Recalling firm
- Firm
- MACLEODS PHARMA USA, INC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 103 College Rd E Fl 2, N/A, Princeton, New Jersey 08540-6611
Distribution
- Quantity
- 10052 bottles
- Distribution pattern
- Nationwide within United States and Puerto Rico.
Timeline
- Recall initiated
- 2023-01-05
- FDA classified
- 2023-01-17
- Posted by FDA
- 2023-01-25
- Terminated
- 2025-06-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0162-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.