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Recall Observatory FDA recall evidence

Drug 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.

D-1042-2013

August 29, 2013

Class II

Product summary

Firm
Dr. Reddy's Laboratories, Inc.
Event
Event 66117
Status
Terminated
Classification
Class II
Quantity
18852 bottles
Official record key
drug-enforcement:D-1042-2013

Official wording

Reason: 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.

Code information: Lot # L300192; Exp. 05/2017

Distribution pattern: Nationwide (& Puerto Rico)

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or missing