Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx on...

FDA Recall #D-0559-2024 — Class II — May 30, 2024

Recall #D-0559-2024 Date: May 30, 2024 Classification: Class II Status: Terminated

Product Description

Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore Maryland, Manufactured by: Lupin Limited, Mandideep, India NDC 68180-407-03

Reason for Recall

Failed Content Uniformity Specifications

Recalling Firm

Lupin Pharmaceuticals Inc. — Baltimore, MD

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

3,552 bottles

Distribution

Nationwide in the US

Code Information

Lot F201519, Expiry: November 2024

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated