Class III
Terminated
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-0738-86
- Recall Initiated
- December 20, 2016
- Posted
- February 1, 2017
- Recall Number
- D-0446-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 11,618 bottles
- Firm Location
- Cranbury, NJ, United States
Reason for Recall
Failed Dissolution Specifications; 18 month stability time point
Distribution
Nationwide
Lot / Code Info
JKP0905A 04/17
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