Why it was recalled
Superpotent Drug
Product description
Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixed) bottles (NDC 68180-402-01); b) 75 mL (when mixed) bottles (NDC 68180-402-02); and c) 100 mL (when mixed) bottles (NDC 68180-402-03); Rx only, Manufactured for: Lupin Pharmaceutical, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Mandideep 462 046, India.
Lot numbers, UPCs & expiration codes
Lot Numbers: a) F801122, exp. date June 2021; b) F801123, exp. date June 2021; c) F801124, exp. date June 2021
Where it was sold
Nationwide in the USA 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-0332-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 26, 2021
- FDA report date
- Apr 21, 2021
- Quantity
- a) 6,816 bottles; b) 3,960 bottles and c) 7,038 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0332-2021, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 87602
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot Numbers: a) F801122, exp. date June 2021; b) F801123, exp. date June 2021; c) F801124, exp. date June 2021
- Postal code
- 21202-6174
- Report date
- Apr 21, 2021
- Product type
- Drugs
- Recall number
- D-0332-2021
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- a) 6,816 bottles; b) 3,960 bottles and c) 7,038 bottles
- Termination date
- Dec 16, 2021
- Reason for recall
- Superpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixed) bottles (NDC 68180-402-01); b) 75 mL (when mixed) bottles (NDC 68180-402-02); and c) 100 mL (when mixed) bottles (NDC 68180-402-03); Rx only, Manufactured for: Lupin Pharmaceutical, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Mandideep 462 046, India.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Mar 26, 2021
- Initial firm notification
- Letter
- Center classification date
- Apr 12, 2021