D-1320-2019 Class II Terminated

Recalled by Lupin Pharmaceuticals Inc. — Baltimore, MD

Recall Details

Product Type
Drugs
Report Date
June 5, 2019
Initiation Date
May 23, 2019
Termination Date
October 22, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
18,408, 60 mL bottles

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.

Distribution Pattern

Distributed Nationwide in the USA

Code Information

Lot # F802335, exp. date November 2020