Venlafaxine Hydrochloride Capsule, Extended Release
FDA Recall NDC 65862-697
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 Hydrochloride (NDC 65862-697). A significant event, classified as Class II, was initiated on Dec 22, 2016 by Aurobindo Pharma Limited. The reported reason for this action was: "Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules."
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 II Terminated
Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
Dec 22, 2016
Feb 22, 2017
47,040 bottles
Recall Profile & Regulatory Data
Event ID
76325
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Termination Date
Mar 19, 2019
Product Description
Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 072 India, NDC 65862-527-30
Batch or Lot Expiration Information
Lot# : VI3716010-A, Exp. 04/2018
Affected Packages Involved in this Recall
65862-527-47Product
65862-527-30Product
65862-527-90Product
65862-527-01Product
65862-527-99Product
65862-527-59Product
65862-527-10Product
65862-528-47Product
65862-528-30Product
65862-528-90Product
65862-528-01Product
65862-528-99Product
65862-528-35Product
65862-528-10Product
65862-697-47Product
65862-697-30Product
65862-697-90Product
65862-697-01Product
65862-697-05Product
65862-697-26Product
65862-697-10Product
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.
