AirDuo Digihaler 113/14 — Class II drug recall D-0024-2022
Terminated recall by Teva Pharmaceuticals USA, reported 2021-10-27, distributed nationwide. Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
| Recall number | D-0024-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Parsippany, NJ, United States |
| Recall initiated | 2021-09-22 |
| Classified | 2021-10-21 |
| Reported by FDA | 2021-10-27 |
| Terminated | 2023-02-16 |
| Distributed | Nationwide (US) |
| Quantity | 4,850 inhalers |
| Reason classes | labeling, potency, specification failure |
| NDC | 59310-0129-06 |
Product
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.
Reason for recall
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0024-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.