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FDAFDA · Food and drugs·Recall number D-0869-2022

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.

Published May 25, 2022 · Recall initiated: March 24, 2022

Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

CGMP Deviations: Failure to properly investigate failed microbial testing.

What to do

Voluntary: Firm initiated · Press Release

Recall details

Manufacturer
Plastikon Healthcare LLC
Distributor
Distributed in Indiana for further distribution in the USA.
Lot
Lot: 20040A, EXP May 2022
Risk classification
Class II
Area (FDA)
drug
Country
United States

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