buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Di...
FDA Recall #D-0446-2017 — Class III — December 20, 2016
Product Description
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
Reason for Recall
Failed Dissolution Specifications; 18 month stability time point
Recalling Firm
Sun Pharmaceutical Industries, Inc. — Cranbury, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
11,618 bottles
Distribution
Nationwide
Code Information
JKP0905A 04/17
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated