Why it was recalled
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Product description
Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-722-04
Lot numbers, UPCs & expiration codes
Lot # F305292, Exp 8/30/2025
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-0497-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 24, 2024
- FDA report date
- May 22, 2024
- Quantity
- 17,040 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0497-2024, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 94492
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot # F305292, Exp 8/30/2025
- Postal code
- 21202-6174
- Report date
- May 22, 2024
- Product type
- Drugs
- Recall number
- D-0497-2024
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 17,040 bottles
- Termination date
- Apr 29, 2025
- Reason for recall
- Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-722-04
- Distribution pattern
- USA nationwide
- Recall initiation date
- Apr 24, 2024
- Initial firm notification
- Letter
- Center classification date
- May 14, 2024