FDA-Drug2021-10-27Class II
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.
Teva Pharmaceuticals USA
Hazard
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Sold states
USA Nationwide
Affected count
4,850 inhalers
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0024-2022Don't want to check this manually?
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