# FDA recall D-0025-2022

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2021-09-22.

## Product

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

## Reason for recall

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

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0025-2022
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-0025-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0025-2022. Source: US FDA. Licensed CC0.

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