FDA-Drug2019-03-13Class III
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
Jubilant Cadista Pharmaceuticals, Inc.
Hazard
Failed Dissolution Specifications; 9-monthstability timepoint
Sold states
Product was distributed to one customer who may have further distributed the product.
Affected count
a) 3,072 bottles; b) 2,688 bottles
Manufactured in
207 Kiley Dr, N/A, Salisbury, MD, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0519-2019Don't want to check this manually?
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