D-0023-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 27, 2021
- Initiation Date
- September 22, 2021
- Termination Date
- February 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,978 inhalers
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
Distribution Pattern
USA Nationwide
Code Information
AFR16A