FDA-Drug2014-04-09Class III

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.

Teva Pharmaceuticals USA
Hazard

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

Sold states
Nationwide
Affected count
257,832 cylinders
Manufactured in
425 Privet Rd, N/A, Horsham, PA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1190-2014

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