Drug recall D-1406-2020

Class II Terminated reported Jul 29, 2020

Product

Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India, NDC 68180-723-20

Reason for recall

Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.

Lots and codes

Lot # F802189, Exp 10/2020, F900240, Exp 1/2021

Recall details

Recalling firm
Lupin Pharmaceuticals Inc., Baltimore, MD
Quantity
35,928 bottles
Distribution
U.S.A. Nationwide
Type
Voluntary: Firm initiated
Recall initiated
July 2, 2020
Terminated
June 30, 2021

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