Recalls / Class III
Class IIID-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.
- Affected 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
Why it was recalled
Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, N/A, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 257,832 cylinders
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-02-11
- FDA classified
- 2014-04-03
- Posted by FDA
- 2014-04-09
- Terminated
- 2014-11-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1190-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.