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ACETAMINOPHEN Recall D-0869-2022

Description: Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76.

ACETAMINOPHEN Recall D-0869-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0869-2022
Event ID89879
BrandACETAMINOPHEN ORAL SOLUTION
Generic NameACETAMINOPHEN ORAL SOLUTION
ManufacturerACETAMINOPHEN ORAL SOLUTION
Original Package?1
Active SubstanceACETAMINOPHEN
Drug RouteORAL
DistributionDistributed in Indiana for further distribution in the USA.
Quantity121,800 Unit Dose cups
Recall ReasonCGMP Deviations: Failure to properly investigate failed microbial testing.
Drug ClassificationClass II
Drug Code Info20220525
Product NDC0904-6738 0904-6739 0904-6740
Drug UPC0309046820765 0309046741725 0309046840725
Recall Initiation Date20220324
Report Date20220525
Classification Date20220513
Address3780 Greenway Cir
Lawrence, KS 66046-5440
United States
Recalling FirmPlastikon Healthcare LLC
Initial Notification Press Release
Unique Ingredient IdentifierTC2D6JAD40 NBZ3QY004S
Drug Application Numberpart343
Structured Product Labeling (SPL ID)d35be1c3-5196-1f51-e053-2a95a90a6bc2
Structured Product Labeling (SPL Set ID)81f30812-60c2-65c0-e053-2991aa0afed6
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