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.
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.
Lot numbers, UPCs & expiration codes
Lot # L300192; Exp. 05/2017
Where it was sold
Nationwide (& Puerto Rico)
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1042-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 29, 2013
- FDA report date
- Sep 25, 2013
- Quantity
- 18852 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-1042-2013, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 66117
- Address
- 200 Somerset Corporate Blvd Fl 7th
- Code information
- Lot # L300192; Exp. 05/2017
- Postal code
- 08807-2862
- Report date
- Sep 25, 2013
- Product type
- Drugs
- Recall number
- D-1042-2013
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 18852 bottles
- Termination date
- Mar 20, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide (& Puerto Rico)
- Recall initiation date
- Aug 29, 2013
- Initial firm notification
- Letter
- Center classification date
- Sep 13, 2013