Product: BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59746-758-90) bottles, Rx only, Manufactured b Jubilant Generis Ltd, Roorkee, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD
Reason for recall: Failed Dissolution Specifications; 9-monthstability timepoint
Recall initiated: 20190228
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated