Recalls / Class II
Class IID-0023-2022
Product
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
- Affected lot / code info
- AFR16A
Why it was recalled
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 1,978 inhalers
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2021-09-22
- FDA classified
- 2021-10-21
- Posted by FDA
- 2021-10-27
- Terminated
- 2023-02-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0023-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.