Drug Enforcement D-1042-2013

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.

Status

Terminated

Classification

Class II

Report Date

September 25, 2013

Termination Date

March 20, 2014

Product Information

Product description
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.
Product quantity
18852 bottles
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.
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
Nationwide (& Puerto Rico)

Location & Firm

Recalling firm
Dr. Reddy's Laboratories, Inc.
Address
200 Somerset Corporate Blvd Fl 7th, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-1042-2013
Event ID
66117
Recall initiation date
August 29, 2013
Center classification date
September 13, 2013
Code info
Lot # L300192; Exp. 05/2017
More code info