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

D-1043-2014 Class III Terminated

Recalled by Actavis Inc — Parsippany, NJ

FDA drug recall D-1043-2014 was initiated by Actavis Inc on Nov 15, 2013 and is designated Class III. Reason for recall: Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months. The recall status is terminated (terminated Jun 16, 2015). Affected quantity: 139,944 bottles.

Recall details

Product Type: Drugs
Report Date: Feb 5, 2014
Initiation Date: Nov 15, 2013
Termination Date: Jun 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

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1043-2014
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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