Drug recall D-0007-2017

Class III Terminated reported Oct 12, 2016

Product

buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by Sun Pharmaceuticals Ind. Ltd. Halol- Baroda Highway, Halol-389 350, Gujarat, India. UPC 347335737868 NDC 47335-737-86

Reason for recall

Failed Dissolution Specifications

Lots and codes

JKN5124A and JKN5229A, exp 10/2016

Recall details

Recalling firm
Sun Pharmaceutical Industries, Inc., Cranbury, NJ
Quantity
31,762 bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
September 13, 2016
Terminated
July 2, 2018

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