PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: June 5, 2019 Initiated: May 23, 2019 #D-1320-2019

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.

Details

Units Affected
18,408, 60 mL bottles
Distribution
Distributed Nationwide in the USA
Location
Baltimore, MD

Frequently Asked Questions

What product was recalled?
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. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 18,408, 60 mL bottles.
Why was this product recalled?
Complaint received of metal piece identified in the product bottle prior to the reconstitution.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 5, 2019. Severity: Moderate. Recall number: D-1320-2019.