Recall Enforment Report D-0023-2022
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Teva Pharmaceuticals USA, originally initiated on 09-22-2021 for the 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 The product was recalled due to subpotent drug: oos results of label claimed emitted dose for salmeterol. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
---|---|---|---|---|---|---|---|
D-0023-2022 | 09-22-2021 | 10-27-2021 | Class II | 1,978 inhalers | 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 | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Terminated |
D-0024-2022 | 09-22-2021 | 10-27-2021 | Class II | 4,850 inhalers | 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. | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Terminated |
D-0025-2022 | 09-22-2021 | 10-27-2021 | Class II | 5,500 inhalers | 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 | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Terminated |
D-0022-2022 | 09-22-2021 | 10-27-2021 | Class II | 3,240 inhalers | 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. | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Terminated |
D-0021-2022 | 09-22-2021 | 10-27-2021 | Class II | 10,665 inhalers | AirDuo Digihaler 113/14 (fluticasone propionate 113 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 59310-520-08 | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Terminated |
Recalled Products
NDC | Proprietary Name | Non-Proprietary Name | Dosage Form | Route Name | Company Name | Product Type |
---|---|---|---|---|---|---|
59310-111 | Airduo Digihaler | Fluticasone Propionate And Salmeterol | Powder, Metered | Respiratory (inhalation) | Teva Respiratory, Llc | Human Prescription Drug |
59310-129 | Airduo Digihaler | Fluticasone Propionate And Salmeterol | Powder, Metered | Respiratory (inhalation) | Teva Respiratory, Llc | Human Prescription Drug |
59310-136 | Airduo Digihaler | Fluticasone Propionate And Salmeterol | Powder, Metered | Respiratory (inhalation) | Teva Respiratory, Llc | Human Prescription Drug |
59310-510 | Airduo Digihaler | Fluticasone Propionate And Salmeterol | Powder, Metered | Respiratory (inhalation) | Teva Respiratory, Llc | Human Prescription Drug |
59310-520 | Airduo Digihaler | Fluticasone Propionate And Salmeterol | Powder, Metered | Respiratory (inhalation) | Teva Respiratory, Llc | Human Prescription Drug |
59310-530 | Airduo Digihaler | Fluticasone Propionate And Salmeterol | Powder, Metered | Respiratory (inhalation) | Teva Respiratory, Llc | Human Prescription Drug |