Recalls / Class II
Class IID-1458-2016
Product
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.
- Affected lot / code info
- Lot #: a) GS011931, Exp 10/2017; GS011932, Exp 11/2017 b) GS010773, GS011242, 09/2017; GS011061, GS011315, GS011357, GS011585, GS011586, GS011588, GS011591, Exp 10/2017; GS011933, Exp 11/2017
Why it was recalled
Failed Dissolution Specifications: Out-of-specification results in retained sample.
Recalling firm
- Firm
- Golden State Medical Supply Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5187 Camino Ruiz, N/A, Camarillo, California 93012-8601
Distribution
- Quantity
- 65,401 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-08-03
- FDA classified
- 2016-08-16
- Posted by FDA
- 2016-08-24
- Terminated
- 2017-02-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1458-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.