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.
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