FDA-Drug2014-02-05Class III

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

Actavis Inc
Hazard

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

Sold states
Nationwide and Puerto Rico
Affected count
139,944 bottles
Manufactured in
400 Interpace Pkwy, Parsippany, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1043-2014

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