Jubilant Cadista Pharmaceuticals, Inc. recalls BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged in a) 60-count bottles (NDC 59746-317-60)…
- Recall date
- April 8, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0671-2017
- FDA classification
- Class III
- Brand / firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
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, packaged in a) 60-count bottles (NDC 59746-317-60) and b) 100-count bottles (NDC 59746-317-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.
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