Product Safety Recalls

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ALBUTEROL SULFATE Recall D-1024-2022

Description: Albuterol Sulfate Inhalation Aerosol HFA 90 mcg, with Dose Indicator, 200 metered inhalations, Rx only, Distributed by: Sandoz Inc., NDC 0781-7296-85

ALBUTEROL SULFATE Recall D-1024-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1024-2022
Event ID89646
BrandALBUTEROL SULFATE
Generic NameALBUTEROL SULFATE
ManufacturerALBUTEROL SULFATE
Original Package?1
Active SubstanceALBUTEROL SULFATE
Drug RouteRESPIRATORY (INHALATION)
DistributionUSA nationwide.
Quantity1 aerosol
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0781-7296
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)bd1b1025-d888-ab5f-e053-2a95a90a22fb
Structured Product Labeling (SPL Set ID)f8a2c4b7-a162-48ab-90b0-350e4da25c66
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