Acetaminophen Oral Solution recalled over manufacturing violations

Recall date

March 24, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Plastikon Healthcare LLC recalls Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institution…

Recall number

D-0869-2022

FDA classification

Class II

Brand / firm

Plastikon Healthcare LLC

Sold / distributed

Distributed in Indiana for further distribution in the USA.

Why it was recalled

CGMP Deviations: Failure to properly investigate failed microbial testing.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.