Sun Pharmaceutical Industries, Inc. recalls buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distribu…
- Recall date
- September 13, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0007-2017
- FDA classification
- Class III
- Brand / firm
- Sun Pharmaceutical Industries, Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Failed Dissolution Specifications
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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