Class III
Terminated
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.
This recall has been terminated (originally issued April 9, 2014).
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- February 11, 2014
- Posted
- April 9, 2014
- Recall Number
- D-1190-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 257,832 cylinders
- Firm Location
- Horsham, PA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point
Distribution
Nationwide
Lot / Code Info
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
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