Product Safety Recalls

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ALBUTEROL SULFATE Recall D-1076-2022

Description: Proair, HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 metered inhalations, Rx only, MFG: Teva Pharma USA, NDC 59310-579-22

ALBUTEROL SULFATE Recall D-1076-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1076-2022
Event ID89646
BrandPROAIR
Generic NameALBUTEROL SULFATE
ManufacturerALBUTEROL SULFATE
Original Package?1
Active SubstanceALBUTEROL SULFATE
Drug RouteRESPIRATORY (INHALATION)
DistributionUSA nationwide.
Quantity56 inhalers
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC59310-579
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 Identifier021SEF3731
Drug Application NumberNDA021457
Structured Product Labeling (SPL ID)07738d64-2ab5-4f96-bce1-f92bbb93ef18
Structured Product Labeling (SPL Set ID)8e701d71-1dcb-4b84-bada-84e4f04f5e62
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