Wound gel recalled for contamination that can cause ‘life-threatening infections’
A gel applied to wounds to prevent microbial infections has been recalled after a bacterial contamination was found in the gel itself.
And that contamination, according to the FDA-posted recall notice by Blaine Labs Company, can make RevitaDerm Wound Care Gel deadly.
Here’s what you need to know.
What’s recalled?
Lot No. BL 2844 of RevitaDerm Wound Care Gel with an expiration date of 02/19/2023. The gel comes in a 1-ounce bottle or a 3-ounce tube and went to 61 physician clinics in 17 states.
Why is it recalled and what’s the danger?
Contamination by the Bacillus cereus bacteria was found in a 1-ounce bottle.
“Patients who apply the contaminated product to a wound could develop a skin and soft tissue infection which could lead to serious complications,” the recall notice’s risk statement says.
If your immune system is normal, the infections “are expected to be less severe and responsive to treatment.”
But, if your immune system is damaged in any way or the wound is on a baby born before 37 weeks of pregnancy, “Bacillus cereus can cause life-threatening, invasive infections including wound and blood infections, sepsis, pneumonia, and meningitis.”
What you should do now
If you’re a patient having a wound treated, make sure your medical professional isn’t using recalled gel. If you were given the gel by a doctor, return it to that doctor. If you’re a medical professional, you should receive email, snail mail and phone calls from Blaine Labs about returning the gel.
Consumers with questions about the recall can email info@blainelabs.com or call Blaine Labs at 800-307-8818, Monday through Friday, 11 a.m. to 7 p.m., Eastern time.
If this or any other drug or drug dispenser causes a medical problem, after notifying a medical professional, let the FDA know via its MedWatch Adverse Event page or by filling out a form you can get by calling 800-332-1088. Then, notify the manufacturer.
This story was originally published January 31, 2022 at 8:12 AM with the headline "Wound gel recalled for contamination that can cause ‘life-threatening infections’."
