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.
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
Lot numbers, UPCs & expiration codes
Lot #: BLF2214A; Exp. 06/2025
Where it was sold
Nationwide within United States and Puerto Rico.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0162-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 5, 2023
- FDA report date
- Jan 25, 2023
- Quantity
- 10052 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- MACLEODS PHARMA USA, INC
Original FDA data
Every field from FDA enforcement report D-0162-2023, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 91441
- Address
- 103 College Rd E Fl 2
- Code information
- Lot #: BLF2214A; Exp. 06/2025
- Postal code
- 08540-6611
- Report date
- Jan 25, 2023
- Product type
- Drugs
- Recall number
- D-0162-2023
- Classification
- Class III
- Recalling firm
- MACLEODS PHARMA USA, INC
- Product quantity
- 10052 bottles
- Termination date
- Jun 24, 2025
- Reason for recall
- Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within United States and Puerto Rico.
- Recall initiation date
- Jan 5, 2023
- Initial firm notification
- Letter
- Center classification date
- Jan 17, 2023