Teva Pharmaceuticals USA: Drug Recall

Recall #D-0025-2022 · 09/22/2021

Class II: Risk

Recall Details

Recall Number: D-0025-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Teva Pharmaceuticals USA
Status: Terminated
Date Initiated: 09/22/2021
Location: Parsippany, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5,500 inhalers

Reason for Recall

Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

Product Description

AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-136-06

Distribution Pattern

USA Nationwide

Other Recalls by Teva Pharmaceuticals USA

Class II: Risk 01/18/2022

Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Class II: Risk 01/10/2022

Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
Class III: Low Risk 01/07/2022

Mislabeling
Class III: Low Risk 01/07/2022

Mislabeling
Class II: Risk 12/31/2021

Lack of Assurance of Sterility

View all recalls by Teva Pharmaceuticals USA →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.