Product Safety Recalls

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ALBUTEROL SULFATE Recall D-1019-2022

Description: Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 5 x 3 mL unit-dose vials, Rx only, Manufactured by: Nephron Pharma, NDC 0487-9501-03

ALBUTEROL SULFATE Recall D-1019-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1019-2022
Event ID89646
BrandALBUTEROL SULFATE
Generic NameALBUTEROL SULFATE
ManufacturerALBUTEROL SULFATE
Original Package?1
Active SubstanceALBUTEROL SULFATE
Drug RouteRESPIRATORY (INHALATION)
DistributionUSA nationwide.
Quantity23 pouches
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0487-9501
Drug UPC0304879501003 0304879501010
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 NumberANDA074880
Structured Product Labeling (SPL ID)b8a75428-95af-d867-e053-2a95a90a6509
Structured Product Labeling (SPL Set ID)574824f3-51cc-4b94-9c10-e3204d8b19f8
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