Why it was recalled
Subpotent Drug
Product description
Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202 United States, Manufactured by: Lupin Limited, Manddeep, 462 046, India, NDC 68180-405-01
Lot numbers, UPCs & expiration codes
Lot #: F900787, Exp. Date 4/2021
Where it was sold
Nationwide within the United States
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-0390-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 29, 2021
- FDA report date
- May 26, 2021
- Quantity
- 3,138 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0390-2021, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 87871
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot #: F900787, Exp. Date 4/2021
- Postal code
- 21202-6174
- Report date
- May 26, 2021
- Product type
- Drugs
- Recall number
- D-0390-2021
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 3,138 bottles
- Termination date
- Feb 22, 2022
- Reason for recall
- Subpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202 United States, Manufactured by: Lupin Limited, Manddeep, 462 046, India, NDC 68180-405-01
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Apr 29, 2021
- Initial firm notification
- Letter
- Center classification date
- May 19, 2021