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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Inhalation Aerosol
- Affected units
- 461,592
Distribution
Distributed nationwide across the United States.
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