FDA recall D-1501-2016

Amerisource Health Services · Class III · drug

Product

buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03

Reason for recall

Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2016-08-04
Report date: 2016-09-21
Termination date: 2017-07-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1501-2016