Teva Recalls QVAR Inhalers Due to Impurity Test Failures
Teva Pharmaceuticals is recalling QVAR inhalers because stability testing revealed out-of-specification impurity results.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Teva Pharmaceuticals USA is recalling QVAR (beclomethasone dipropionate HFA 40 mcg) inhalation aerosols. The recall involves 233,364 units of the 40 mcg strength, 120-metered inhalation product, marketed by Teva Respiratory, LLC., and manufactured by 3M Drug Delivery Systems. The affected lots are 130449 and 130450, with an expiration date of 12/2015.
The recall was initiated due to failed impurities and degradation specifications. Specifically, stability testing resulted in out-of-specification test results for an impurity. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should stop using the affected QVAR inhalers and contact their healthcare provider or pharmacist for guidance on replacement or alternative treatment options.
The recalled product
- Product
- QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For Oral Inhalation with QVAR Actuator Only, 120 metered inhalations, Rx Only, Mktd by Teva Respiratory, LLC., Horsham, PA. mfd by 3M Drug Delivery Systems, Northridge, CA, NDC 59310-0202-12
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Inhalation Aerosol
- Hazard
- Affected units
- 233,364
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #s:130449
- 130450
- Exp. Date: 12/2015
Distribution
Distributed nationwide across the United States.
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