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 ongoing.

Recall Enforcement Reports

Recall Number Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0023-202209-22-202110-27-2021Class II1,978 inhalersAirDuo 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 59310-111-06Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterolOngoing
D-0024-202209-22-202110-27-2021Class II4,850 inhalersAirDuo 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 salmeterolOngoing
D-0025-202209-22-202110-27-2021Class II5,500 inhalersAirDuo Digihaler 232/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-136-06Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterolOngoing
D-0022-202209-22-202110-27-2021Class II3,240 inhalersAirDuo 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 salmeterolOngoing
D-0021-202209-22-202110-27-2021Class II10,665 inhalersAirDuo 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 59310-520-08Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterolOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
59310-111Airduo Digihaler Fluticasone Propionate And SalmeterolPowder, MeteredRespiratory (inhalation)Teva Respiratory, LlcHuman Prescription Drug
59310-129Airduo Digihaler Fluticasone Propionate And SalmeterolPowder, MeteredRespiratory (inhalation)Teva Respiratory, LlcHuman Prescription Drug
59310-136Airduo Digihaler Fluticasone Propionate And SalmeterolPowder, MeteredRespiratory (inhalation)Teva Respiratory, LlcHuman Prescription Drug
59310-510Airduo Digihaler Fluticasone Propionate And SalmeterolPowder, MeteredRespiratory (inhalation)Teva Respiratory, LlcHuman Prescription Drug
59310-520Airduo Digihaler Fluticasone Propionate And SalmeterolPowder, MeteredRespiratory (inhalation)Teva Respiratory, LlcHuman Prescription Drug
59310-530Airduo Digihaler Fluticasone Propionate And SalmeterolPowder, MeteredRespiratory (inhalation)Teva Respiratory, LlcHuman Prescription Drug