Teva Pharmaceuticals USA recalls AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Te…
- Recall date
- September 22, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0024-2022
- FDA classification
- Class II
- Brand / firm
- Teva Pharmaceuticals USA
- Sold / distributed
- USA Nationwide
Why it was recalled
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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