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FDAFDA · Food and drugs·Recall number D-175-2013

buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: America Health Packaging Columbus, OH 43217

Published March 6, 2013 · Recall initiated: January 4, 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; 8-hours for the 18-month stability testing point.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Actavis Pharmaceuticals
Distributor
Nationwide
Lot
Lot CB1D05A,
Risk classification
Class III
Area (FDA)
drug
Country
United States

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