The Recall Desk
SevereFDA (Drugs)·D-1341-2014·Announced 2014-05-28

Teva Recalls QVAR Inhalation Aerosol Due to Defective Valve

Teva Pharmaceuticals is recalling QVAR inhalation aerosol canisters because the delivery system and valve are defective.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), as the agency's own classification mandates a minimum score of 4.

Plain-English summary

Teva Pharmaceuticals USA is recalling QVAR (beclomethasone dipropionate HFA) 80mcg Inhalation Aerosol. The product is packaged in an aluminum cylinder and is available in 50 metered inhalation and 120 metered inhalation sizes. The recall involves 461,592 canisters that were distributed nationwide.

The recall is being issued because the product has a defective delivery system and a defective valve. The agency has classified this recall as Class II.

Consumers who have this product should stop using it and contact Teva Pharmaceuticals USA for instructions on how to return the product or obtain a refund.

The recalled product

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 units
461,592

Distribution

Distributed nationwide across the United States.