D-0332-2021 Class II Terminated
FDA drug recall D-0332-2021 was initiated by Lupin Pharmaceuticals Inc. on March 26, 2021 and is designated Class II. Reason for recall: Superpotent Drug The recall status is terminated (terminated December 16, 2021). Affected quantity: a) 6,816 bottles; b) 3,960 bottles and c) 7,038 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 21, 2021
- Initiation Date
- March 26, 2021
- Termination Date
- December 16, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 6,816 bottles; b) 3,960 bottles and c) 7,038 bottles
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.
Reason for Recall
Superpotent Drug
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Lot Numbers: a) F801122, exp. date June 2021; b) F801123, exp. date June 2021; c) F801124, exp. date June 2021