FDAFDA · Food and drugs·Recall number D-0007-2017
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by Sun Pharmaceuticals Ind. Ltd. Halol- Baroda Highway, Halol-389 350, Gujarat, India. UPC 347335737868 NDC 47335-737-86
Published October 12, 2016 · Recall initiated: September 13, 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
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Brand
- BUPROPION HYDROCHLORIDE
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Distributor
- Nationwide
- UPC
- 0347335738865
- Lot
- JKN5124A and JKN5229A, exp 10/2016
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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