FDAFDA · Food and drugs·Recall number D-1501-2016
buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03
Published September 21, 2016 · Recall initiated: August 4, 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 out of specification result for dissolution was identified during 3 month stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Amerisource Health Services
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot #: MS1509, Exp 12/17
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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