RecallDepth
Class II Terminated

Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01

Company
Lupin Pharmaceuticals Inc.
Recall Initiated
August 21, 2024
Posted
September 4, 2024
Recall Number
D-0648-2024
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
4554 bottles
Firm Location
Baltimore, MD, United States

Reason for Recall

Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.

Distribution

USA nationwide.

Lot / Code Info

Lot #: F201517, Exp 11/30/2024

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