PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: April 9, 2014 Initiated: February 11, 2014 #D-1190-2014

Product Description

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.

Reason for Recall

Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point

Details

Recalling Firm
Teva Pharmaceuticals USA
Units Affected
257,832 cylinders
Distribution
Nationwide
Location
Horsham, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Teva Pharmaceuticals USA. Units affected: 257,832 cylinders.
Why was this product recalled?
Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point
Which agency issued this recall?
This recall was issued by the FDA Drug on April 9, 2014. Severity: Low. Recall number: D-1190-2014.