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Jubilant Cadista Pharmaceuticals, Inc. Recall: BuPROPion Hydrochloride Extended-release Ta

Jubilant Cadista Pharmaceuticals, Inc. Recall: BuPROPion Hydrochloride Extended-release Ta is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Jubilant Cadista Pharmaceuticals, Inc.; Product: BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a) 60-count bottle

Recalling firmJubilant Cadista Pharmaceuticals, Inc.
ProductBuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a) 60-count bottles (NDC 59746-316-60) and b) 100-count bottles (NDC 59746-316-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.
Reason for recallFailed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
ClassificationClass III (least serious — unlikely to cause adverse health consequences)
StatusTerminated
DistributionNationwide in the USA
Recall initiated20160408
Recall numberD-0670-2017
Categorydrug
StateMD
CountryUnited States

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