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LEVALBUTEROL TARTRATE Recall D-1067-2022

Description: Levalbuterol Tartrate HFA Inhalation Aerosol, 45 mcg/actuation, 200 metered inhalations, Rx only, MFG: Teva Pharma USA, NDC 0591-2927-54

LEVALBUTEROL TARTRATE Recall D-1067-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1067-2022
Event ID89646
BrandLEVALBUTEROL TARTRATE HFA INHALATION
Generic NameLEVALBUTEROL TARTRATE
ManufacturerLEVALBUTEROL TARTRATE
Original Package?1
Active SubstanceLEVALBUTEROL TARTRATE
Drug RouteORAL
DistributionUSA nationwide.
Quantity2 inhalers
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0591-2927
Recall Initiation Date20220413
Report Date20220615
Classification Date20220609
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient IdentifierADS4I3E22M
Drug Application NumberNDA021730
Structured Product Labeling (SPL ID)c202555a-0ee9-4534-bfef-22a3a9da64e0
Structured Product Labeling (SPL Set ID)ac85703a-17a2-4f0b-87f4-78f1756d2f85
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