FDA-Drug2021-10-27Class II

AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-136-06

Teva Pharmaceuticals USA
Hazard

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

Sold states
USA Nationwide
Affected count
5,500 inhalers
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-136-06

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0025-2022

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