FDAFDA · Food and drugs·Recall number D-0671-2017
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged in a) 60-count bottles (NDC 59746-317-60) and b) 100-count bottles (NDC 59746-317-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.
Published April 19, 2017 · Recall initiated: April 8, 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 Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Jubilant Cadista Pharmaceuticals, Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot #s: a) BU34002A, BU34003A, Exp 11/16; b) BU34001A, Exp 10/16
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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