CLASS III Drug recall · Reported 21 Nov 2012 · FDA Enforcement Report

Venlafaxine ER 150mg, 30 Tabs, Generic for: Effexor, Packaged recalled

Stat Rx USA is recalling Venlafaxine ER 150mg, 30 Tabs, Generic for: Effexor, Packaged, distributed in Georgia, Tennessee. The recall was initiated on 23 Aug 2012 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot # A00984 Exp. 01/14
Quantity recalled5 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-051-2013
FDA event ID
63659
Recalling firm
Stat Rx USA, Gainesville, GA
Classification
Class III
Status
Terminated
Recall initiated
23 Aug 2012
FDA classified
9 Nov 2012
Reported
21 Nov 2012
Type
Voluntary: Firm initiated
Customers notified by
E-Mail
Reason category
Labeling Errors
Drug class
Antidepressants

Timeline

23 Aug 2012Recall initiated by company
9 Nov 2012Classified by FDA+78 days
21 Nov 2012Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules."

Product as listed by the FDA

Venlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor, Packaged and Distributed by: Stat Rx USA, LLC, Gainesville, GA 30501 NDC 42549-684-30

Where it was distributed

GA and TN.

GeorgiaTennessee

Questions about this recall

Why was it recalled?

Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules."

Which lots are affected?

Lot # A00984 Exp. 01/14

Where was it sold?

GA and TN.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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