Recall D-0648-2024

US Class II Terminated · initiated 2024-08-21

Recalling firm

Lupin Pharmaceuticals Inc., MD

Product

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

Reason for recall

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

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