FDAFDA · Food and drugs·Recall number D-0446-2017
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-0738-86
Published February 1, 2017 · Recall initiated: December 20, 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; 18 month stability time point
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Distributor
- Nationwide
- Lot
- JKP0905A 04/17
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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