Recalls / Class II
Class IID-1042-2013
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.
- Brand name
- Ibu
- Generic name
- Ibuprofen
- Active ingredient
- Ibuprofen
- Route
- Oral
- NDCs
- 55111-682, 55111-683, 55111-684
- FDA application
- ANDA075682
- Affected lot / code info
- Lot # L300192; Exp. 05/2017
Why it was 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.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 200 Somerset Corporate Blvd Fl 7th, N/A, Bridgewater, New Jersey 08807-2862
Distribution
- Quantity
- 18852 bottles
- Distribution pattern
- Nationwide (& Puerto Rico)
Timeline
- Recall initiated
- 2013-08-29
- FDA classified
- 2013-09-13
- Posted by FDA
- 2013-09-25
- Terminated
- 2014-03-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1042-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.