Sun Pharmaceutical Industries, Inc. recalls buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Phar…
- Recall date
- December 20, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0446-2017
- FDA classification
- Class III
- Brand / firm
- Sun Pharmaceutical Industries, Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Failed Dissolution Specifications; 18 month stability time point
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
Get recall alerts
Free email alert whenever Sun Pharmaceutical Industries, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Sun Pharmaceutical Industries, Inc.