Recalls / Class II
Class IID-1341-2014
Product
QVAR¿ (beclomethasone dipropionate HFA), 80mcg Inhalation Aerosol, 50 metered inhalations/120 metered inhalations, packaged in an aluminum cylinder, Mktd. by: Teva Respiratory, LLC, Horsham, PA, Mfd. by: 3M Drug Delivery Systems, Northridge, CA.
- Affected lot / code info
- 130140 11/2014 59310-204-85 80 mcg 4.2g / 50 metered inhalations 130143 3/2015 59310-204-80 80 mcg 8.7g / 120 metered inhalations 130144 3/2015 59310-204-80 80 mcg 8.7g / 120 metered inhalations
Why it was recalled
Defective Delivery System; defective valve
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, N/A, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 461,592 canisters
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-04-23
- FDA classified
- 2014-05-20
- Posted by FDA
- 2014-05-28
- Terminated
- 2015-03-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1341-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.