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.
FDA recall notice · announced August 24, 2016 · Golden State Medical Supply
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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.
Reason for recall
Failed Dissolution Specifications: Out-of-specification results in retained sample.
Notes
Distribution: Nationwide
Lot/code information: 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
Quantity: 65,401 bottles
Status: Terminated
Products in this recall event:
- Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per bottle, Rx Only, GSMS, NDC # 60429-122-90 (D-1459-2016)
- 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. (D-1458-2016)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.