PlainRecalls
FDA Drug Moderate Class II Terminated

Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules per bottle, NDC # 60429-123-30, b) 90 capsules per bottle, NDC # 60429-123-90, Rx Only, GSMS.

Reported: August 24, 2016 Initiated: August 3, 2016 #D-1458-2016

Product Description

Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules per bottle, NDC # 60429-123-30, b) 90 capsules per bottle, NDC # 60429-123-90, Rx Only, GSMS.

Reason for Recall

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

Details

Units Affected
65,401 bottles
Distribution
Nationwide
Location
Camarillo, CA

Frequently Asked Questions

What product was recalled?
Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules per bottle, NDC # 60429-123-30, b) 90 capsules per bottle, NDC # 60429-123-90, Rx Only, GSMS.. Recalled by Golden State Medical Supply Inc.. Units affected: 65,401 bottles.
Why was this product recalled?
Failed Dissolution Specifications: Out-of-specification results in retained sample.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 24, 2016. Severity: Moderate. Recall number: D-1458-2016.