Jubilant Cadista Pharmaceuticals, Inc. recalls BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59
Recalled March 13, 2019 · FDA recall D-0519-2019 · Jubilant Cadista Pharmaceuticals
Hazard
Failed Dissolution Specifications; 9-monthstability timepoint · FDA Class III
Units
a) 3,072 bottles; b) 2,688 bottles
Sold at
Product was distributed to one customer who may have further distributed the product.
Description
Failed Dissolution Specifications; 9-monthstability timepoint
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
Manufacturer(s)
Jubilant Cadista Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →