Medicine recalls
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| The United States: Plastikon Healthcare issues voluntary nationwide recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide ／Aluminum Hydroxide ／Simethicone Oral Suspension due to microbial contamination |
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The US Food and Drug Administration (FDA) announces that Plastikon Healthcare, LLC is voluntarily recalling the following products to the consumer level:
- Milk of Magnesia 2400 mg/10 ml Oral Suspension (lot number: 20074A)
- Milk of Magnesia 2400 mg/30 ml Oral Suspension (lot number: 20071A)
- Magnesium Hydroxide 1200 mg/Aluminum Hydroxide 1200 mg/Simethicone 120 mg per 30 ml Oral Suspension (lot number: 21103A, 20046A, 20079A, 20080A, 20081A, 21057A, 21059A, 21095A, 21096A, 21099A, 21115A)
- Magnesium Hydroxide 2400 mg/Aluminum Hydroxide 2400 mg/Simethicone 240 mg per 30 ml Oral Suspension (lot number: 20051A, 20088A)
The products are being recalled due to microbial contamination.
Administration or use of oral drug products with microbial contamination could potentially result in increased infections that may require medical intervention. Patients with compromised immune systems, such as patients in hospitals and nursing homes, have a higher probability of developing potentially life-threatening infections after taking a contaminated product. To date, Plastikon Healthcare has not received any reports of adverse events or injuries 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-and-magnesium
In Hong Kong, the above products are not registered pharmaceutical products. There is also no registered pharmaceutical product manufactured by Plastikon Healthcare.
Ends/Thursday, Jun 9, 2022
Issued at HKT 14:00
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