Why it was recalled
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
Product description
Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India, NDC 68180-723-20
Lot numbers, UPCs & expiration codes
Lot # F802189, Exp 10/2020, F900240, Exp 1/2021
Where it was sold
U.S.A. 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-1406-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 2, 2020
- FDA report date
- Jul 29, 2020
- Quantity
- 35,928 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1406-2020, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 85960
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot # F802189, Exp 10/2020, F900240, Exp 1/2021
- Postal code
- 21202-6174
- Report date
- Jul 29, 2020
- Product type
- Drugs
- Recall number
- D-1406-2020
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 35,928 bottles
- Termination date
- Jun 30, 2021
- Reason for recall
- Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India, NDC 68180-723-20
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Jul 2, 2020
- Initial firm notification
- Letter
- Center classification date
- Jul 23, 2020