Plastikon Healthcare LLC: Drug Recall

Recall #D-0869-2022 · 03/24/2022

Class II: Risk

Recall Details

Recall Number: D-0869-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Plastikon Healthcare LLC
Status: Completed
Date Initiated: 03/24/2022
Location: Lawrence, KS, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 121,800 Unit Dose cups

Reason for Recall

CGMP Deviations: Failure to properly investigate failed microbial testing.

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.

Distribution Pattern

Distributed in Indiana for further distribution in the USA.

Other Recalls by Plastikon Healthcare LLC

Class II: Risk 06/07/2022

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II: Risk 06/07/2022

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II: Risk 06/07/2022

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II: Risk 06/07/2022

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II: Risk 06/07/2022

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

View all recalls by Plastikon Healthcare LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.