Home / Recalls / Plastikon Healthcare LLC / D-0869-2022

D-0869-2022 Class II

Recalled by Plastikon Healthcare LLC — Lawrence, KS

Recall Details

Product Type: Drugs
Report Date: May 25, 2022
Initiation Date: March 24, 2022
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 121,800 Unit Dose cups

Product Description

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.

Reason for Recall

CGMP Deviations: Failure to properly investigate failed microbial testing.

Distribution Pattern

Distributed in Indiana for further distribution in the USA.

Code Information

Lot: 20040A, EXP May 2022

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