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The potential presence of a harmful contaminant could cause serious infection.
If you’re using any medication for treatment of a wound, surgical incision, or even just skin irritation, it’s time to check your medicine cabinet. That’s because there’s a new recall of a drug used to treat a number of issues due to a potentially dangerous contaminant—and it could cause serious consequences. Read on to find out more about the latest recall, and what you should do if you have this medication at home.
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According to a statement posted on the website for the U.S. Food & Drug Administration (FDA), Blaine Labs Company is voluntarily recalling one lot of RevitaDerm Wound Care Gel. That’s because a bottle of 1-ounce wound care gel has been found to be contaminated with the bacteria Bacillus cereus.
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If patients apply a product that is contaminated to a wound, it could lead to a soft tissue infection, which could in turn result in serious complications. For people who aren’t immunocompromised, symptoms would likely be far less severe and would respond to treatment. But for those who are, Bacillus cereus can cause serious infections that can even be life-threatening. These include wound and blood infections, sepsis, pneumonia, and meningitis.
Fortunately, Blaine Labs Company has not received any reports of health problems as a result of using either its 1-ounce bottles or 3-ounce tubes of RevitaDerm Wound Care Gel.
The recalled product is used as a skin wound antimicrobial treatment. It is packaged in a 1-ounce bottle as well as a 3-ounce tube. Each is labeled as “RevitaDerm Wound Care Gel” and has a drug facts label on the back.
The affected RevitaDerm Wound Care Gel lot is BL 2844 with an expiration date of Feb. 19, 2023. The product’s name is on the front of the 1-ounce bottle or 3-ounce tube, and the one-ounce product has a witch-hat-style dispensing cap (tall and pointy). The RevitaDerm Wound Care Gel Product was distributed to 61 physician clinics in 17 states last year.
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Blaine Labs is notifying its doctor clients by email, regular mail, and by phone, and is arranging for the return of undispensed bottles and tubes from lot BL 2844. But if you already have a recalled RevitaDerm Wound Care Gel 1-ounce bottle or 3-ounce tube at home, you should stop using it immediately and return any unused part of it to the doctor who dispensed it to you.
If you have any questions about the recall, you can contact Blaine Labs at 800-307-8818 or email firstname.lastname@example.org Monday through Friday from 8 a.m. to 4 p.m. PST. If you think you’ve experienced any health issues related to using this product, call your doctor.
You can report any reactions or quality issues to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail using this downloadable form, or by fax to 800-FDA-0178.
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