Recall: D-0648-2024

Class II - Potentially Harmful

Class IIClassification

2024-08-21Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

Product

Cefixime for Oral Suspension USP, 100 mg/5 mL, 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

Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.

Distribution

USA nationwide.

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