Recall: D-1320-2019

Class II - Potentially Harmful

Class IIClassification

2019-05-23Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

Product

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

Complaint received of metal piece identified in the product bottle prior to the reconstitution.

Distribution

Distributed Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.