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  3. Recall Enforcement Event ID: 76982

Recall Enforment Report D-0669-2017

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Jubilant Cadista Pharmaceuticals, Inc., originally initiated on 04-08-2016 for the product BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746-315-60) and b) 100-count bottles (NDC 59746-315-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA. The product was recalled due to failed impurities/degradation specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0669-201704-08-201604-19-2017Class III20,882 bottlesBuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746-315-60) and b) 100-count bottles (NDC 59746-315-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.Terminated
D-0671-201704-08-201604-19-2017Class III19,682 bottlesBuPROPion 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.Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.Terminated
D-0670-201704-08-201604-19-2017Class III81,077 bottlesBuPROPion 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.Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.Terminated