Drug recall D-0306-2020

Class III Terminated reported Nov 13, 2019

Product

Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA

Reason for recall

Presence of Foreign substance: identified as a dead ant.

Lots and codes

Lot #: a) F900153, Exp 11/20; b) F802327, F802328, F802329, Exp 11/20

Recall details

Recalling firm
Lupin Pharmaceuticals Inc., Baltimore, MD
Quantity
a) 4074 bottles b) 30,300 bottles
Distribution
Product was distributed to major distributors/wholesalers throughout the United States.
Type
Voluntary: Firm initiated
Recall initiated
November 1, 2019
Terminated
March 4, 2021

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