Drug recall D-1446-2016

Class III Terminated reported Jul 27, 2016

Product

buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol 389-350 Gujarat India ---- NDC 47335-737-86

Reason for recall

Failed Dissolution Specifications

Lots and codes

Lot JKN3477A, exp 07/2016

Recall details

Recalling firm
Sun Pharmaceutical Industries, Inc., Cranbury, NJ
Quantity
16,085 bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
June 27, 2016
Terminated
March 27, 2018

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