FDAClass IISeptember 25, 2013

IBU (tm) Ibuprofen Tablets recall: Labeling Error

IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Rx only, Distributed by Dr. Reddy's Laboratories, Inc., Bridgewater, NJ 08807 USA.

Why was IBU (tm) Ibuprofen Tablets recalled?

Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.

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 # L300192; Exp. 05/2017

Product
IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Rx only, Distributed by Dr. Reddy's Laboratories, Inc., Bridgewater, NJ 08807 USA.
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
18852 bottles
Distribution
Nationwide (& Puerto Rico)
Recall date
September 25, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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