Multi-event August 2016 FDA Recall Drug by Golden State Medical Supply Inc.

This Multi-event Class II drug recall was voluntarily initiated by Golden State Medical Supply Inc. on August 3, 2016 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1459-2016 TERMINATED D-1458-2016 TERMINATED

Recall Number: D-1459-2016

Reason for Recall
Failed Dissolution Specifications: Out-of-specification results in retained sample.
Initiated
08-03-2016
Reported
08-24-2016
Quantity
40,631 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74847
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Golden State Medical Supply Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-02-2017
Product Description About Product Description
Full technical description of the product.
Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per bottle, Rx Only, GSMS, NDC # 60429-122-90

Batch or Lot Expiration Information

Lot# : GS011692, GS011938, Exp 10/2017; GS012638, GS012639, Exp 11/2017

Recall Number: D-1458-2016

Reason for Recall
Failed Dissolution Specifications: Out-of-specification results in retained sample.
Initiated
08-03-2016
Reported
08-24-2016
Quantity
65,401 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74847
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Golden State Medical Supply Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-02-2017
Product Description About Product Description
Full technical description of 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.

Batch or Lot Expiration 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