FDA-Drug2022-05-25Class II
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.
Plastikon Healthcare LLC
Hazard
CGMP Deviations: Failure to properly investigate failed microbial testing.
Sold states
Distributed in Indiana for further distribution in the USA.
Affected count
121,800 Unit Dose cups
Manufactured in
3780 Greenway Cir, N/A, Lawrence, KS, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0869-2022Don't want to check this manually?
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