FDA recall D-0519-2019

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

Distribution

Product was distributed to one customer who may have further distributed the product.

Key facts

Status

Terminated

Initiation date

2019-02-28

Report date

2019-03-13

Termination date

2020-03-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salisbury, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0519-2019