Why it was recalled
Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.
Product description
buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, Manufactured By: Sun Pharmaceutical Ind. Ltd., Halol Baroda Highway, Halol 389 350, Gujarat, India, NDC 47335-738-86
Lot numbers, UPCs & expiration codes
Lot #s: JKM4152A, JKM4737A, JKM5270A, Exp 08/2015
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-1345-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 17, 2015
- FDA report date
- Aug 26, 2015
- Quantity
- 35,235 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sun Pharma Global Fze
Original FDA data
Every field from FDA enforcement report D-1345-2015, exactly as published.
Show all FDA fields
- City
- Sharm
- Status
- Terminated
- Country
- United Arab Emirates
- Event ID
- 71949
- Address
- Office # 43 Block Y Saif Zone
- Code information
- Lot #s: JKM4152A, JKM4737A, JKM5270A, Exp 08/2015
- Report date
- Aug 26, 2015
- Product type
- Drugs
- Recall number
- D-1345-2015
- Classification
- Class III
- Recalling firm
- Sun Pharma Global Fze
- Product quantity
- 35,235 bottles
- Termination date
- Mar 22, 2016
- Reason for recall
- Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, Manufactured By: Sun Pharmaceutical Ind. Ltd., Halol Baroda Highway, Halol 389 350, Gujarat, India, NDC 47335-738-86
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jul 17, 2015
- Initial firm notification
- Letter
- Center classification date
- Aug 14, 2015