Drug recall D-1345-2015
Product
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
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.
Lots and codes
Lot #s: JKM4152A, JKM4737A, JKM5270A, Exp 08/2015
Recall details
- Recalling firm
- Sun Pharma Global Fze, Sharm
- Quantity
- 35,235 bottles
- Distribution
- Nationwide and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 17, 2015
- Terminated
- March 22, 2016
Related products
- Bupropion hydrochloride – drug information
- NDC 47335-737 Bupropion hydrochloride · Bupropion Hydrochloride 150 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-736 Bupropion hydrochloride · Bupropion Hydrochloride 100 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-738 Bupropion hydrochloride · Bupropion Hydrochloride 200 mg/1 · Sun Pharmaceutical Industries, Inc.