Lawrence, KS, Plastikon Healthcare, LLC is voluntarily recalling three (3) lots of Milk of Magnesia 2400 mg/30 mL Oral Suspension, one (1) lot of Acetaminophen 650mg/ 20.3mL, and six (6) lots of Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL to the hospital, clinic and patient level.

The products are being recalled due to microbial contamination and failure to properly investigate failed microbial testing.

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Risk Statement: This product potentially could result in illness due to intestinal distress, such as diarrhea or abdominal pain.

Individuals with a compromised immune system have a higher probability of developing a wide-spread, potentially life-threatening infection when ingesting or otherwise orally exposed to products contaminated by micro-organisms.

To date, Plastikon has not received any customer complaints related to microbial concerns or reports of adverse events related to this recall.

Product indication, lot numbers, expiration dates and NDC information are listed in the table below. The product is packaged for institutional use and is sold to clinics and hospitals nationwide in single use cups with a foil lid.

The affected lots were distributed to Major Pharmaceuticals Distribution Center (wholesaler) between 5/1/2020 and 6/28/2021, who shipped to hospitals, nursing homes, and clinics nationwide. The products are private labeled for Major Pharmaceuticals.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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