Drug product
AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC , Frazer, PA 19355, Manufactured in Ireland, NDC 59310-520-08
D-0021-2022
Product summary
- Event
- Event 88738
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,665 inhalers
- Official record key
drug-enforcement:D-0021-2022
Official wording
Reason: Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Code information: AFR17A
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent