Why it was recalled
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Product description
Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01
Lot numbers, UPCs & expiration codes
Lot #: F201517, Exp 11/30/2024
Where it was sold
USA nationwide.
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-0648-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 21, 2024
- FDA report date
- Sep 4, 2024
- Quantity
- 4554 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0648-2024, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 95193
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot #: F201517, Exp 11/30/2024
- Postal code
- 21202-6174
- Report date
- Sep 4, 2024
- Product type
- Drugs
- Recall number
- D-0648-2024
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 4554 bottles
- Termination date
- Apr 29, 2025
- Reason for recall
- Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01
- Distribution pattern
- USA nationwide.
- Recall initiation date
- Aug 21, 2024
- Initial firm notification
- Letter
- Center classification date
- Aug 26, 2024