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ACETAMINOPHEN Recall D-1348-2022

Description: Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; NDC 36000-306-60

ACETAMINOPHEN Recall D-1348-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1348-2022
Event ID90699
BrandACETAMINOPHEN
Generic NameACETAMINOPHEN
ManufacturerACETAMINOPHEN
Original Package?1
Active SubstanceACETAMINOPHEN
Drug RouteINTRAVENOUS
DistributionNationwide in the USA
Quantity85,680 bags
Recall ReasonTemperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.
Drug ClassificationClass II
Drug Code Info20220824
Product NDC36000-306
Recall Initiation Date20220804
Report Date20220824
Classification Date20220816
Address1 Baxter Pkwy
Deerfield, IL 60015-4625
United States
Recalling FirmBaxter Healthcare Corporation
Initial Notification Letter
Unique Ingredient Identifier362O9ITL9D
Drug Application NumberANDA214331
Structured Product Labeling (SPL ID)3b1e4460-7502-442c-850c-76adfa404f87
Structured Product Labeling (SPL Set ID)0f67c1bd-915b-4681-88dd-22f5154a80b3
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