February 2014 FDA Recall Drug by Teva Pharmaceuticals Usa
D-1190-2014 - Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point

This Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on February 11, 2014 for the product Drug. The FDA reported the reason for recall as failed impurity/degradation specification; for 17-bmp at the 9 and 18 month stability time point. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1190-2014

Reason for Recall
Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point
Initiated
02-11-2014
Reported
04-09-2014
Quantity
257,832 cylinders

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67564
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-14-2014
Product Description About Product Description
Full technical description of the product.
QVAR¿ (beclomethasone dipropionate HFA), C4 INHALATION AEROSOL in Aluminum Cylinders, Mktd by: Teva Respiratory, LLC, Horsham, PA 19044 Mfd by: 3M Drug Delivery Systems, Northridge, CA 91324.

Batch or Lot Expiration Information

Lot# lot 120088, exp.3/2014, NDC 59310-202-40, 40 mcg,8.7g / 120 metered inhalations, lot 120491, exp. 10/2014, NDC 59310-175-41,40 mcg,7.3g / 100 metered inhalations