Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, M...
FDA Recall #D-1320-2019 — Class II — May 23, 2019
Product Description
Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 20201, Manufactured by: Lupin Limited, Mandideep 462 046 India. NDC 68180-723-20
Reason for Recall
Complaint received of metal piece identified in the product bottle prior to the reconstitution.
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
18,408, 60 mL bottles
Distribution
Distributed Nationwide in the USA
Code Information
Lot # F802335, exp. date November 2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated