AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-530-08.
Reported: October 27, 2021 Initiated: September 22, 2021 #D-0022-2022
Product Description
AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-530-08.
Reason for Recall
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 3,240 inhalers
- Distribution
- USA Nationwide
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-530-08.. Recalled by Teva Pharmaceuticals USA. Units affected: 3,240 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-0022-2022.
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