FDA recall D-1042-2013

Dr. Reddy's Laboratories, Inc. · Class II · 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.

Reason for recall

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.

Distribution

Nationwide (& Puerto Rico)

Key facts

Status
Terminated
Initiation date
2013-08-29
Report date
2013-09-25
Termination date
2014-03-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1042-2013