Why it was recalled
Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
Product description
Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01
Lot numbers, UPCs & expiration codes
Lot #: F800779, Expiry 4/2020
Where it was sold
Nationwide with the United States and Puerto Rico.
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-1252-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 15, 2020
- FDA report date
- Apr 29, 2020
- Quantity
- 4,518 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1252-2020, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 85487
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot #: F800779, Expiry 4/2020
- Postal code
- 21202-6174
- Report date
- Apr 29, 2020
- Product type
- Drugs
- Recall number
- D-1252-2020
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 4,518 bottles
- Termination date
- Jun 7, 2021
- Reason for recall
- Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01
- Distribution pattern
- Nationwide with the United States and Puerto Rico.
- Recall initiation date
- Apr 15, 2020
- Initial firm notification
- Letter
- Center classification date
- Apr 23, 2020