Drug 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
D-1087-2015
Product summary
- Event
- Event 71140
- Status
- Terminated
- Classification
- Class III
- Quantity
- 233,364 Inhalers
- Official record key
drug-enforcement:D-1087-2015
Official wording
Reason: Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.
Code information: Lot #s:130449, 130450; Exp. Date: 12/2015
Distribution pattern: Nationwide and Peurto Rico
Derived failure modes
-
Potency or specification failure
out of specification