Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) ...
FDA Recall #D-0306-2020 — Class III — November 1, 2019
Product Description
Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA
Reason for Recall
Presence of Foreign substance: identified as a dead ant.
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
a) 4074 bottles b) 30,300 bottles
Distribution
Product was distributed to major distributors/wholesalers throughout the United States.
Code Information
Lot #: a) F900153, Exp 11/20; b) F802327, F802328, F802329, Exp 11/20
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated