PlainRecalls
FDA Drug Moderate Class II Terminated

Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by:Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01

Reported: February 7, 2024 Initiated: January 3, 2024 #D-0274-2024

Product Description

Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by:Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01

Reason for Recall

Failed Impurities/Degradation Specifications

Details

Units Affected
4,608 Bottles
Distribution
Nationwide in the USA
Location
Baltimore, MD

Frequently Asked Questions

What product was recalled?
Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by:Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 4,608 Bottles.
Why was this product recalled?
Failed Impurities/Degradation Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on February 7, 2024. Severity: Moderate. Recall number: D-0274-2024.