Home / Recalls / Actavis Inc / D-1043-2014

D-1043-2014 Class III Terminated

Recalled by Actavis Inc — Parsippany, NJ

Recall Details

Product Type
Drugs
Report Date
February 5, 2014
Initiation Date
November 15, 2013
Termination Date
June 16, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
139,944 bottles

Product Description

BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laboratories, Inc. Corona, CA 92880

Reason for Recall

Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lots: 524099M, 524100A, 521687A

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