FDA recall D-1459-2016

Golden State Medical Supply Inc. · Class II · drug

Product

Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per bottle, Rx Only, GSMS, NDC # 60429-122-90

Reason for recall

Failed Dissolution Specifications: Out-of-specification results in retained sample.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2016-08-03
Report date
2016-08-24
Termination date
2017-02-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Camarillo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1459-2016