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.
FDA recall notice · announced April 9, 2014 · Teva Pharmaceuticals
Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.
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.
Reason for recall
Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point
Notes
Distribution: Nationwide
Lot/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
Quantity: 257,832 cylinders
Status: Terminated
Products in this recall event:
- 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)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.