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D-1484-2022 Class II Terminated

Recalled by Plastikon Healthcare LLC — Lawrence, KS

FDA drug recall D-1484-2022 was initiated by Plastikon Healthcare LLC on Jun 7, 2022 and is designated Class II. Reason for recall: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. The recall status is terminated (terminated Jun 25, 2025). Affected quantity: 290,270 cups.

Recall details

Product Type: Drugs
Report Date: Sep 14, 2022
Initiation Date: Jun 7, 2022
Termination Date: Jun 25, 2025
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 290,270 cups

Product description

Acetaminophen Oral Solution 160 mg / 5 mL, 5 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 0904-6738-70

Reason for recall

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

Distribution pattern

Distributed Nationwide in the USA

Code information

Lot# 20078A, 20083A EXP Aug. 2022; 20092A, EXP Sep. 2022; 21058A, 21048C, EXP May. 2023; 21063C, EXP Jun. 2023; 21093B, EXP Sep. 2023; 22001C, EXP Jan. 2024; 22017A, EXP Mar. 2024.

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1484-2022
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

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

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