FDAClass IIFebruary 7, 2024

Cefixime for Oral Suspension 100mg/5mL recall: Impurity Out of Spec

Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured…

Why was Cefixime for Oral Suspension 100mg/5mL recalled?

Failed Impurities/Degradation Specifications

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: F304833, Exp 06/2025

Product
Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured…
Recalling firm
Lupin Pharmaceuticals Inc.
Quantity
4,608 Bottles
Distribution
Nationwide in the USA
Recall date
February 7, 2024
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls