Medicine recalls
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| The United States: Blaine Labs issues voluntary nationwide recall of RevitaDerm Wound Care Gel due to bacterial contamination |
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The US Food and Drug Administration (FDA) announces that Blaine Labs Company is voluntarily recalling one lot of RevitaDerm Wound Care Gel (benzalkonium chloride) (lot number: BL 2844) to the consumer level because a bottle of the 1.0 ounce RevitaDerm Wound Care Gel has been found to be contaminated with Bacillus cereus.
Patients who apply the contaminated product to a wound could develop a skin and soft tissue infection which could lead to serious complications. For non-immunocompromised patients these infections are expected to be less severe and responsive to treatment. However, for the immunocompromised patients and preterm neonates, Bacillus cereus can cause life-threatening, invasive infections including wound and blood infections, sepsis, pneumonia, and meningitis. To date, Blaine Labs Company has not received any complaints or reports of adverse events related to this lot of 1.0 ounce bottle or 3.0 ounce tube of RevitaDerm Wound Care Gel.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/blaine-labs-issues-voluntary-nationwide-recall-revitaderm-wound-care-gel-due-bacterial-contamination
In Hong Kong, the above product is not a registered pharmaceutical product. There is also no registered pharmaceutical product manufactured by the above company.
Ends/Friday, Jan 28, 2022
Issued at HKT 14:00
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