Status
Terminated
Drug Enforcement D-0162-2023
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Classification
Class III
Report Date
January 25, 2023
Termination Date
June 24, 2025
Product Information
- 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
- Product quantity
- 10052 bottles
- Reason for recall
- Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within United States and Puerto Rico.
Location & Firm
- Recalling firm
- MACLEODS PHARMA USA, INC
- Address
-
103 College Rd E Fl 2, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0162-2023
- Event ID
- 91441
- Recall initiation date
- January 5, 2023
- Center classification date
- January 17, 2023
- Code info
- Lot #: BLF2214A; Exp. 06/2025
- More code info
- —