Drug product
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.
D-0332-2021
Product summary
- Event
- Event 87602
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 6,816 bottles; b) 3,960 bottles and c) 7,038 bottles
- Official record key
drug-enforcement:D-0332-2021
Official wording
Reason: Superpotent Drug
Code information: Lot Numbers: a) F801122, exp. date June 2021; b) F801123, exp. date June 2021; c) F801124, exp. date June 2021
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
Superpotent