AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Frazer, PA 19355, Manufactured in Ireland, NDC 59310-111-06

Recall Number: D-0023-2022

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 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Frazer, PA 19355, Manufactured in Ireland, NDC 59310-111-06