Plastikon Healthcare LLC recalls Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutiona
Recalled May 25, 2022 · FDA recall D-0869-2022 · Plastikon Healthcare
Hazard
CGMP Deviations: Failure to properly investigate failed microbial testing. · FDA Class II
Units
121,800 Unit Dose cups
Sold at
Distributed in Indiana for further distribution in the USA.
Description
CGMP Deviations: Failure to properly investigate failed microbial testing.
Product
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.
Manufacturer(s)
Plastikon Healthcare LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →