FDA recall D-0021-2022

Product

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

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-0021-2022