FDAFDA · Food and drugs·Recall number D-1043-2014
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
Published February 5, 2014 · Recall initiated: November 15, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BUPROPION HYDROCHLORIDE
- Manufacturer
- Actavis Inc
- Distributor
- Nationwide and Puerto Rico
- UPC
- 0305913331303
- Lot
- Lots: 524099M, 524100A, 521687A
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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