D-0024-2022 Class II Terminated
FDA drug recall D-0024-2022 was initiated by Teva Pharmaceuticals USA on September 22, 2021 and is designated Class II. Reason for recall: Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol The recall status is terminated (terminated February 16, 2023). Affected quantity: 4,850 inhalers.
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
- 4,850 inhalers
Product Description
AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-129-06.
Reason for Recall
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Distribution Pattern
USA Nationwide
Code Information
AFR17A