Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, M...
FDA Recall #D-0497-2024 — Class II — April 24, 2024
Product Description
Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-722-04
Reason for Recall
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
17,040 bottles
Distribution
USA nationwide
Code Information
Lot # F305292, Exp 8/30/2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated