December 2013 FDA Recall Drug by Teva Pharmaceuticals Usa
D-382-2014 - Defective Delivery System

This Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on December 4, 2013 for the product Drug. The FDA reported the reason for recall as defective delivery system. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-382-2014

Reason for Recall
Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves.
Initiated
12-04-2013
Reported
01-01-2014
Quantity
379,463 inhalers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67010
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 Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-27-2014
Product Description About Product Description
Full technical description of the product.
Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 metered sprays, 8.7 g inhaler, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Delivery Systems, Northridge, CA 91324, NDC 59310-210-12, UPC 3 59310 21012 9.

Batch or Lot Expiration Information

Lot# : 120004, Exp 01/14; 120095, 120131, 120131 2, Exp 03/14; 120271, Exp 07/14; 120351, Exp 08/14