AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Frazer, PA 19355, Manufactured in Ireland, NDC 59310-111-06
Reported: October 27, 2021 Initiated: September 22, 2021 #D-0023-2022
Product Description
AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Frazer, PA 19355, Manufactured in Ireland, NDC 59310-111-06
Reason for Recall
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 1,978 inhalers
- Distribution
- USA Nationwide
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Frazer, PA 19355, Manufactured in Ireland, NDC 59310-111-06. Recalled by Teva Pharmaceuticals USA. Units affected: 1,978 inhalers.
Why was this product recalled? ▼
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 27, 2021. Severity: Moderate. Recall number: D-0023-2022.
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