FDAFDA · Food and drugs·Recall number D-0137-2017
Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories
Published November 23, 2016 · Recall initiated: October 27, 2016
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: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Amerisource Health Services
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot #: a) M601509, Exp 3/31/2018; M606506, Exp 4/30/2018; b) M601510, Exp 3/31/2018; M604444, Exp 4/30/2018; M606515, Exp 4/30/2018.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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