Medicine recalls
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| The United States: Plastikon Healthcare expands 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 issuing an update to the voluntary recall initiated on 3 Jun 2022. The recall has been expanded to include Lot 20076A of Magnesium Hydroxide 1200 mg / Aluminum Hydroxide 1200 mg / Simethicone 120 mg per 30 ml Oral Suspension. This lot was previously subject to a retail level recall and has been added to the current consumer level recall based on updated microorganism speciation data from third-party testing.
Administration or use of 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-expands-voluntary-nationwide-recall-milk-magnesia-oral-suspension-and-magnesium
In Hong Kong, the above product is not a registered pharmaceutical product. There is also no registered pharmaceutical product manufactured by Plastikon Healthcare. Related news was previously issued by FDA, and was posted on the Drug Office website on 9 Jun 2022.
Ends/Friday, Aug 5, 2022
Issued at HKT 13:00
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