Drug product
AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-136-06
D-0025-2022
Product summary
- Event
- Event 88738
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,500 inhalers
- Official record key
drug-enforcement:D-0025-2022
Official wording
Reason: Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Code information: AFR18A
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent