Why it was recalled
Failed Impurities/Degradation Specifications
Product description
Cefixime for Oral Suspension 100mg/5mL, 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 #: F304833, Exp 06/2025
Where it was sold
Nationwide in the USA
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-0274-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 3, 2024
- FDA report date
- Feb 7, 2024
- Quantity
- 4,608 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0274-2024, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 93730
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot #: F304833, Exp 06/2025
- Postal code
- 21202-6174
- Report date
- Feb 7, 2024
- Product type
- Drugs
- Recall number
- D-0274-2024
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 4,608 Bottles
- Termination date
- Dec 27, 2024
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cefixime for Oral Suspension 100mg/5mL, 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
- Nationwide in the USA
- Recall initiation date
- Jan 3, 2024
- Initial firm notification
- Letter
- Center classification date
- Jan 26, 2024