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ISOPROPYL ALCOHOL Recall D-1151-2022

Description: 70% ISOPROPYL ALCOHOL First aid antiseptic, 4 FL OZ (118 mL) bottle, Made in US with US and foreign components for Medline Industries, Inc., Mundelein, IL 60060 USA, NDC: 53329-798-04, UPC (01) 10888277362291.

ISOPROPYL ALCOHOL Recall D-1151-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1151-2022
Event ID90453
BrandISOPROPYL ALCOHOL
Generic NameISOPROPYL ALCOHOL
ManufacturerISOPROPYL ALCOHOL
Original Package?1
Active SubstanceISOPROPYL ALCOHOL
Drug RouteTOPICAL
DistributionNationwide in the USA
Quantity3,157,620 bottles
Recall ReasonDefective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and insufficient tightening.
Drug ClassificationClass II
Drug Code Info20220629
Product NDC53329-798
Recall Initiation Date20220615
Report Date20220629
Classification Date20220621
Address1 Swan Dr
Smyrna, TN 37167-2099
United States
Recalling FirmVi-Jon, LLC
Initial Notification Letter
Unique Ingredient IdentifierND2M416302
Drug Application Numberpart333A
Structured Product Labeling (SPL ID)cdb04731-2b23-b46e-e053-2a95a90adc18
Structured Product Labeling (SPL Set ID)d980969d-694b-4c9e-a931-73beaceb51da
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