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| The United States: Plastikon Healthcare issues voluntary nationwide recall of Milk of Magnesia Oral Suspension 2400mg／30ml, Magnesium Hydroxide 1200mg／Aluminum Hydroxide 1200mg／Simethicone 120mg per 30ml, and Acetaminophen 650mg／20.3ml, Unit Dose Cups, due to microbial contamination (English only) |
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The US Food and Drug Administration (FDA) announces that Plastikon Healthcare, LLC is voluntarily recalling the following products to the hospital, clinic and patient level. The products are being recalled due to microbial contamination and failure to properly investigate failed microbial testing. The affected products are:
- Milk of Magnesia Oral Suspension 2400mg/30ml (lot number: 20024A, 20025A, 20041A)
- Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 ml (lot number: 20042A, 20043A, 20045A, 20046A, 20047A, 21067A)
- Acetaminophen 650mg/20.3ml (lot number: 20040A)
These products 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.
The products are packaged for institutional use and are sold to clinics and hospitals nationwide in single use cups with a foil lid. The products are private labeled for Major Pharmaceuticals.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/plastikon-healthcare-issues-voluntary-nationwide-recall-milk-magnesia-oral-suspension-2400-mg30-ml-0
In Hong Kong, the above products are not registered pharmaceutical products. There is also no registered pharmaceutical product manufactured by Plastikon Healthcare.
Ends/Friday, Mar 25, 2022
Issued at HKT 15:00
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