May 2015 FDA Recall Drug by Teva Pharmaceuticals Usa
D-1087-2015 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on May 7, 2015 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1087-2015

Reason for Recall
Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.
Initiated
05-07-2015
Reported
06-03-2015
Quantity
233,364 Inhalers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71140
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Peurto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-15-2016
Product Description About Product Description
Full technical description of the product.
QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For Oral Inhalation with QVAR Actuator Only, 120 metered inhalations, Rx Only, Mktd by Teva Respiratory, LLC., Horsham, PA. mfd by 3M Drug Delivery Systems, Northridge, CA, NDC 59310-0202-12

Batch or Lot Expiration Information

Lot# s:130449, 130450; Exp. Date: 12/2015