Product Safety Recalls

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ALBUTEROL SULFATE Recall D-1090-2022

Description: Proventil HFA, (Albuterol Sulfate Inhalation Aerosol), 200 metered inhalations, Rx only, MFG: Merck Company, NDC 0085-1132-04

ALBUTEROL SULFATE Recall D-1090-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1090-2022
Event ID89646
BrandPROVENTIL HFA
Generic NameALBUTEROL SULFATE
ManufacturerALBUTEROL SULFATE
Original Package?1
Active SubstanceALBUTEROL SULFATE
Drug RouteRESPIRATORY (INHALATION)
DistributionUSA nationwide.
Quantity22 inhalers
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0085-1132
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 NumberNDA020503
Structured Product Labeling (SPL ID)bd0c720f-c140-401e-e053-2a95a90a970d
Structured Product Labeling (SPL Set ID)0f8fd0fb-97bc-479e-a9e9-104ea7b230e7
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