FDA recall D-0137-2017

Amerisource Health Services · Class III · drug

Product

Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories

Reason for recall

Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2016-10-27
Report date: 2016-11-23
Termination date: 2017-06-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0137-2017