Venlafaxine Tablet
FDA Recall NDC 63629-3324
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Venlafaxine (NDC 63629-3324). A significant event, classified as Class III, was initiated on Mar 25, 2016 by Bryant Ranch Prepack. The reported reason for this action was: "Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation.
Mar 25, 2016
May 11, 2016
21 bottles (910 extended release tablets)
Recall Profile & Regulatory Data
Event ID
73683
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Bryant Ranch Prepack Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Aug 29, 2016
Product Description
Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), b) 100-count bottle (NDC 63629-3324-6), Rx Only, Manufactured by Teva Pharmaceuticals USA, Inc. Packaged by Bryant Ranch.
Batch or Lot Expiration Information
Lot# 94983; Exp 10/17
Affected Packages Involved in this Recall
63629-3324-1Product
63629-3324-2Product
63629-3324-3Product
63629-3324-4Product
63629-3324-5Product
63629-3324-6Product
36290-3324-2Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
