December 2016 FDA Recall Drug by Aurobindo Pharma Usa Inc
D-0474-2017 - Failed Tablet/Capsule Specifications
This Class II drug recall was voluntarily initiated by Aurobindo Pharma Usa Inc on December 22, 2016 for the product Drug. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0474-2017
Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
12-22-2016
02-22-2017
47,040 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the US
03-19-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
