Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pha...
FDA Recall #D-0648-2024 — Class II — August 21, 2024
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
Reason for Recall
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
4554 bottles
Distribution
USA nationwide.
Code Information
Lot #: F201517, Exp 11/30/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated