FDAClass IIJanuary 23, 2019

Cephalexin for Oral Suspension USP recall: CGMP Deviations

Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland…

Why was Cephalexin for Oral Suspension USP recalled?

CGMP Deviation; manufacturing batch record could not be located

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 # F602820, Expiry December 2019

Product
Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland…
Recalling firm
Lupin Pharmaceuticals Inc.
Quantity
7,215 bottles
Distribution
Product was distributed to 12 major distributors who may have further distributed the product throughout the United States.
Recall date
January 23, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls