Plastikon Healthcare LLC: Drug Recall

Recall #D-0871-2022 · 03/24/2022

Class II: Risk

Recall Details

Recall Number: D-0871-2022
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: 106,400 Unit Dose cups

Reason for Recall

CGMP Deviations: Failure to properly investigate failed microbial testing.

Product Description

Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.

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.