Teva Recalls QVAR Inhalers Due to Impurity Specification Failures
Teva Pharmaceuticals is recalling specific lots of QVAR inhalation aerosol because they failed impurity specifications during stability testing.
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 recall is classified as FDA 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 specific lots of QVAR (beclomethasone dipropionate HFA) inhalation aerosol. The recall involves 257,832 aluminum cylinders distributed nationwide. The affected products are identified by NDC 59310-202-40 (Lot 120088, exp. 3/2014) and NDC 59310-175-41 (Lot 120491, exp. 10/2014).
The recall was initiated because the product failed an impurity/degradation specification for 17-BMP at the 9 and 18-month stability time points. This is a Class III recall, which indicates that the violation is not likely to cause adverse health consequences.
Consumers with these specific lots should stop using the product and contact their healthcare provider or pharmacist for guidance on replacement or alternative treatment options.
The recalled product
- Product
- QVAR¿ (beclomethasone dipropionate HFA), C4 INHALATION AEROSOL in Aluminum Cylinders, Mktd by: Teva Respiratory, LLC, Horsham, PA 19044 Mfd by: 3M Drug Delivery Systems, Northridge, CA 91324.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Inhalation Aerosol
- Hazard
- Affected units
- 257,832
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 (9)
- lot 120088
- exp.3/2014
- NDC 59310-202-40
- 40 mcg
- 8.7g / 120 metered inhalations
- lot 120491
- exp. 10/2014
- NDC 59310-175-41
- 7.3g / 100 metered inhalations
Distribution
Distributed nationwide across the United States.
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