Recall: D-1252-2020

Class II - Potentially Harmful

Class IIClassification

2020-04-15Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

Product

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

Reason

Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.

Distribution

Nationwide with the United States and Puerto Rico.

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