Recall: D-1043-2014

Class III - Minor Violations

Class IIIClassification

2013-11-15Initiated

TerminatedStatus

Actavis IncFirm

Product

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

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

Distribution

Nationwide and Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.