Drug recall D-0332-2021

Class II Terminated reported Apr 21, 2021

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.

Reason for recall

Superpotent Drug

Lots and codes

Lot Numbers: a) F801122, exp. date June 2021; b) F801123, exp. date June 2021; c) F801124, exp. date June 2021

Recall details

Recalling firm
Lupin Pharmaceuticals Inc., Baltimore, MD
Quantity
a) 6,816 bottles; b) 3,960 bottles and c) 7,038 bottles
Distribution
Nationwide in the USA and Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
March 26, 2021
Terminated
December 16, 2021

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