FDAFDA · Food and drugs·Recall number D-0149-2017
BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534, NDC 68382-354-05
Published November 30, 2016 · Recall initiated: August 3, 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: Product did not meet dissolution specification at an intermediate time point.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BUPROPION
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Distributor
- Nationwide
- Lot
- Lot #: MR3365, Exp. Feb 17
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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