FDA-Drug2022-09-14Class II

Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6739-71

Plastikon Healthcare LLC
Hazard

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Sold states
Distributed Nationwide in the USA
Affected count
848,500 cups
Manufactured in
3780 Greenway Cir, N/A, Lawrence, KS, United States
Products
Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6739-71

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1485-2022

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