Recalls / Class II
Class IID-1459-2016
Product
Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per bottle, Rx Only, GSMS, NDC # 60429-122-90
- Affected lot / code info
- Lot #: GS011692, GS011938, Exp 10/2017; GS012638, GS012639, 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
- 40,631 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-1459-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.