Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufact...
FDA Recall #D-0474-2017 — Class II — December 22, 2016
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
Reason for Recall
Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
Recalling Firm
Aurobindo Pharma USA Inc — Plainsboro, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
47,040 bottles
Distribution
Nationwide in the US
Code Information
Lot #: VI3716010-A, Exp. 04/2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated