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Recall Observatory FDA recall evidence

Drug 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.

D-1458-2016

August 03, 2016

Class II

Product summary

Firm
Golden State Medical Supply Inc.
Event
Event 74847
Status
Terminated
Classification
Class II
Quantity
65,401 bottles
Official record key
drug-enforcement:D-1458-2016

Official wording

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

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

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out-of-specification