Why it was recalled
Failed Dissolution Specifications; 12 month stability time point
Product description
Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles and 90-count bottles, RX only, Manufactured for Sun Pharma Global Inc. Dubai, United Arab Emirates by Sun Pharmaceutical Industries Limited, Halol, India
Lot numbers, UPCs & expiration codes
Batch Number: JKM3855A Mfg. Date: 06/25/2013 Exp. Date: 05/31/2015 Batch Number: JKM3855B Mfg. Date: 06/25/2013 Exp. Date: 05/31/2015 Batch Number: JKM7265A Mfg. Date: 12/25/2013 Exp. Date: 11/30/2015 Batch Number: JKM7265B Mfg. Date: 12/25/2013 Exp. Date: 11/30/2015
Where it was sold
Nationwide and 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-0236-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 26, 2014
- FDA report date
- Nov 12, 2014
- Quantity
- 68194
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sun Pharma Global Inc.
Original FDA data
Every field from FDA enforcement report D-0236-2015, exactly as published.
Show all FDA fields
- City
- Dubai
- Status
- Terminated
- Country
- United Arab Emirates
- Event ID
- 69370
- Address
- P.O. Box 12850
- Code information
- Batch Number: JKM3855A Mfg. Date: 06/25/2013 Exp. Date: 05/31/2015 Batch Number: JKM3855B Mfg. Date: 06/25/2013 Exp. Date: 05/31/2015 Batch Number: JKM7265A Mfg. Date: 12/25/2013 Exp. Date: 11/30/2015 Batch Number: JKM7265B Mfg. Date: 12/25/2013 Exp. Date: 11/30/2015
- Report date
- Nov 12, 2014
- Product type
- Drugs
- Recall number
- D-0236-2015
- Classification
- Class II
- Recalling firm
- Sun Pharma Global Inc.
- Product quantity
- 68194
- Termination date
- May 6, 2015
- Reason for recall
- Failed Dissolution Specifications; 12 month stability time point
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles and 90-count bottles, RX only, Manufactured for Sun Pharma Global Inc. Dubai, United Arab Emirates by Sun Pharmaceutical Industries Limited, Halol, India
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Sep 26, 2014
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Nov 4, 2014