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.