Class III
Terminated
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
- Company
- Sun Pharma Global Fze
- Recall Initiated
- July 17, 2015
- Posted
- August 26, 2015
- Recall Number
- D-1345-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 35,235 bottles
- Firm Location
- Sharm, United Arab Emirates
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
Nationwide and Puerto Rico
Lot / Code Info
Lot #s: JKM4152A, JKM4737A, JKM5270A, Exp 08/2015
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