Class II

Drug Recall: 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,

Lupin Pharmaceuticals Inc. · August 21, 2024

Reason for Recall

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

Product Description

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

Distribution

USA nationwide.

States Affected

NATIONWIDE

Quantity Affected

4554 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0648-2024

Status: terminated

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.