Multi-event November 2016 FDA Recall Drug by Teva Pharmaceuticals Usa

This Multi-event Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on November 1, 2016 for the product Drug. The FDA reported the reason for recall as failed content uniformity. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0171-2017 TERMINATED D-0170-2017 TERMINATED

Recall Number: D-0171-2017

Reason for Recall
Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Initiated
11-01-2016
Reported
12-14-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75565
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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-06-2018
Product Description About Product Description
Full technical description of the product.
Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-210-13.

Batch or Lot Expiration Information

Lot# : 150335, 150336, Exp. 4/2017

Recall Number: D-0170-2017

Reason for Recall
Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Initiated
11-01-2016
Reported
12-14-2016
Quantity
201, 234 Canisters

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75565
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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-06-2018
Product Description About Product Description
Full technical description of the product.
Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-206-06 and 59310-206-08 (Physician Samples).

Batch or Lot Expiration Information

Lot# : 150096, Exp. 3/2017
Lot# : 150327, Exp. 10/2017