FDA recall D-1190-2014

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.

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-02-11

Report date

2014-04-09

Termination date

2014-11-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Horsham, PA, United States

Primary source

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