April 2014 FDA Recall Drug by Teva Pharmaceuticals Usa
D-1341-2014 - Defective Delivery System; defective valve

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on April 23, 2014 for the product Drug. The FDA reported the reason for recall as defective delivery system; defective valve. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1341-2014

Reason for Recall
Defective Delivery System; defective valve
Initiated
04-23-2014
Reported
05-28-2014
Quantity
461,592 canisters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68121
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-09-2015
Product Description About Product Description
Full technical description of the product.
QVAR¿ (beclomethasone dipropionate HFA), 80mcg Inhalation Aerosol, 50 metered inhalations/120 metered inhalations, packaged in an aluminum cylinder, Mktd. by: Teva Respiratory, LLC, Horsham, PA, Mfd. by: 3M Drug Delivery Systems, Northridge, CA.

Batch or Lot Expiration Information

Lot# 130140 11/2014 59310-204-85 80 mcg 4.2g / 50 metered inhalations 130143 3/2015 59310-204-80 80 mcg 8.7g / 120 metered inhalations 130144 3/2015 59310-204-80 80 mcg 8.7g / 120 metered inhalations