FDAFDA · Food and drugs·Recall number D-1345-2015
buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, Manufactured By: Sun Pharmaceutical Ind. Ltd., Halol Baroda Highway, Halol 389 350, Gujarat, India, NDC 47335-738-86
Published August 26, 2015 · Recall initiated: July 17, 2015
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 Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BUPROPION HYDROCHLORIDE
- Manufacturer
- Sun Pharma Global Fze
- Distributor
- Nationwide and Puerto Rico
- UPC
- 0347335738865
- Lot
- Lot #s: JKM4152A, JKM4737A, JKM5270A, Exp 08/2015
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United Arab Emirates
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