July 2016 FDA Recall Drug by Teva North America
D-1453-2016 - Failed Content Uniformity Specifications

This Class III drug recall was voluntarily initiated by Teva North America on July 15, 2016 for the product Drug. The FDA reported the reason for recall as failed content uniformity specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1453-2016

Reason for Recall
Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.
Initiated
07-15-2016
Reported
08-10-2016
Quantity
193,320 canisters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74700
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 North America
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.
03-10-2017
Product Description About Product Description
Full technical description of the product.
Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray, 60 Metered Sprays per canister, 4.9g Net Contents, Rx only; Professional Sample; Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Drug Delivery Systems, Northridge, CA 91324; NDC 59310-206-08.

Batch or Lot Expiration Information

Lot# 150328, Exp 10/17