Why it was recalled
Defective container: lack of seal integrity.
Product description
Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180-723-04
Lot numbers, UPCs & expiration codes
Lot #F305184, F305185, F305186, Exp 7/31/ 2025
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-0518-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 8, 2024
- FDA report date
- Jun 5, 2024
- Quantity
- 51,006 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0518-2024, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 94602
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot #F305184, F305185, F305186, Exp 7/31/ 2025
- Postal code
- 21202-6174
- Report date
- Jun 5, 2024
- Product type
- Drugs
- Recall number
- D-0518-2024
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 51,006 bottles
- Termination date
- Apr 29, 2025
- Reason for recall
- Defective container: lack of seal integrity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180-723-04
- Distribution pattern
- USA Nationwide
- Recall initiation date
- May 8, 2024
- Initial firm notification
- Letter
- Center classification date
- May 29, 2024