BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-...
FDA Recall #D-1043-2014 — Class III — November 15, 2013
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.
Recalling Firm
Actavis Inc — Parsippany, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
139,944 bottles
Distribution
Nationwide and Puerto Rico
Code Information
Lots: 524099M, 524100A, 521687A
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated