Product Safety Recalls

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ALBUTEROL SULFATE Recall D-1018-2022

Description: Albuterol Sulfate Inhalation Solution, 0.021%, 0.63 mg/3mL, packaged in 30 x 3 mL Sterile Unit-Dose Vials, Rx only, MFG: Nephron Pharma, NDC 0487-0301-01

ALBUTEROL SULFATE Recall D-1018-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1018-2022
Event ID89646
BrandALBUTEROL SULFATE
Generic NameALBUTEROL SULFATE
ManufacturerALBUTEROL SULFATE
Original Package?1
Active SubstanceALBUTEROL SULFATE
Drug RouteRESPIRATORY (INHALATION)
DistributionUSA nationwide.
Quantity1 carton/30 pouches each
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0487-0301 0487-9904
Drug UPC0304879904019 0304870301015
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 NumberANDA076355
Structured Product Labeling (SPL ID)b8a6cb0d-0000-5734-e053-2995a90abd12
Structured Product Labeling (SPL Set ID)285a656c-f77f-4e77-b0a8-a0e9c901803f
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