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
Product summary
- 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
Labeling: Incorrect or missing