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

FDA recall notice · announced February 5, 2014 · Actavis

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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 for recall

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

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lots: 524099M, 524100A, 521687A
Quantity: 139,944 bottles
Status: Terminated
Products in this recall event:
- 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 (D-1043-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.