FDA recall D-0023-2022

Teva Pharmaceuticals USA · Class II · drug

Product

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

Reason for recall

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

Distribution

USA Nationwide

Key facts

Status: Terminated
Initiation date: 2021-09-22
Report date: 2021-10-27
Termination date: 2023-02-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0023-2022