AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-129-06.

Recall Number: D-0024-2022

Firm: Teva Pharmaceuticals USA

Classification: Class II

Status: Terminated

Report Date: 20211027

Initiation Date: 20210922

Termination Date: 20230216

Reason for Recall

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

Product Description

AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-129-06.