Drug 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.

D-1341-2014

April 23, 2014

Class II

Product summary

Firm: Teva Pharmaceuticals USA
Event: Event 68121
Status: Terminated
Classification: Class II
Quantity: 461,592 canisters
Official record key: drug-enforcement:D-1341-2014

Official wording

Reason: Defective Delivery System; defective valve

Code information: 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

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Defective Delivery System; defective valve