Drug 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.

D-1190-2014

February 11, 2014

Class III

Product summary

Firm: Teva Pharmaceuticals USA
Event: Event 67564
Status: Terminated
Classification: Class III
Quantity: 257,832 cylinders
Official record key: drug-enforcement:D-1190-2014

Official wording

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

Code information: 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

Distribution pattern: Nationwide

Derived failure modes

Potency or specification failure
reason.potency_specification_failure · v1.0.0

Failed Impurity/Degradation Specification