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D-0869-2022 Class II

Recalled by Plastikon Healthcare LLC — Lawrence, KS

FDA drug recall D-0869-2022 was initiated by Plastikon Healthcare LLC on Mar 24, 2022 and is designated Class II. Reason for recall: CGMP Deviations: Failure to properly investigate failed microbial testing. Affected quantity: 121,800 Unit Dose cups.

Recall Details

Product Type: Drugs
Report Date: May 25, 2022
Initiation Date: Mar 24, 2022
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

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0869-2022
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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