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

Recall Number: D-0021-2022

Firm: Teva Pharmaceuticals USA

Classification: Class II

Status: Terminated

Report Date: 20211027

Initiation Date: 20210922

Termination Date: 20230216

Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

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