D-1345-2015 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 26, 2015
- Initiation Date
- July 17, 2015
- Termination Date
- March 22, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,235 bottles
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
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.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #s: JKM4152A, JKM4737A, JKM5270A, Exp 08/2015