Recalls / Class III
Class IIID-1087-2015
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
- Affected lot / code info
- Lot #s:130449, 130450; Exp. Date: 12/2015
Why it was recalled
Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 233,364 Inhalers
- Distribution pattern
- Nationwide and Peurto Rico
Timeline
- Recall initiated
- 2015-05-07
- FDA classified
- 2015-05-28
- Posted by FDA
- 2015-06-03
- Terminated
- 2016-11-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1087-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.