Plastikon Healthcare LLC: Drug Recall

Recall #D-1479-2022 · 06/07/2022

Class I: Dangerous

Recall Details

Recall Number: D-1479-2022
Classification: Class I
Product Type: Drug
Recalling Firm: Plastikon Healthcare LLC
Status: Terminated
Date Initiated: 06/07/2022
Location: Lawrence, KS, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 43,200 cups

Reason for Recall

Microbial Contamination of Non-Sterile Products.

Product Description

Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 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 0904-6839-73

Distribution Pattern

Distributed Nationwide 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.