FDAClass IISeptember 4, 2024

Cefixime for Oral Suspension USP recall: Subpotent

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

Why was Cefixime for Oral Suspension USP recalled?

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

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 #: F201517, Exp 11/30/2024

Product
Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202…
Recalling firm
Lupin Pharmaceuticals Inc.
Quantity
4554 bottles
Distribution
USA nationwide.
Recall date
September 4, 2024
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls