FDA MedWatch - Wound Care Gel Products by Blaine Labs

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TOPIC: Wound Care Gel Products by Blaine Labs: Recall - Due to Microbial Contamination

AUDIENCE: Consumer, Patient, Health Care Professional, Pharmacy, Dermatology, Cardiology, Neurology

ISSUE: Blaine Labs is recalling three (3) lot numbers of Wound Care Gel products, 1 oz. & 3 oz. (0.1% Benzalkonium Chloride) due to microbial contamination. The affected product has been found to contain Lysinibacillus fusiformis, an environmental organism.

Risk Statement: This voluntary recall has been initiated as a precautionary measure due to the detection of microbial presence. The tested samples identified the presence of Lysinibacillus fusiformis, which is an environmental spore-forming bacterium.

While it is generally considered to have low pathogenicity in healthy individuals, it can survive in adverse conditions and may act as an opportunistic organism. Patients with open wounds, compromised skin barriers, or weakened immune systems (e.g., elderly, diabetic, or immunocompromised individuals) may be at increased risk for infection, skin irritation, and / or delayed wound healing. In immunocompromised individuals, including those with poorly controlled diabetes, elderly individuals with immune senescence, and young children with an immature immune system, these infections may become severe and lead to life-threatening complications such as endocarditis or central system infection.

To date, Blaine Labs has not received any reports of adverse events related to this recall.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: The product is used as a topical antiseptic for first aid to help prevent the risk of infection in minor cuts, scrapes, and burns.

RECOMMENDATIONS: 

• Customers & Healthcare providers should review their inventory for these affected lot number and discontinue use and / or distribution immediately. Immediately stop using the product. Segregate any remaining inventory of these lot numbers and please contact Blaine Labs, Inc to arrange for return.

• Blaine Labs, Inc. is notifying its physician clinics by regular mail and by phone, as applicable, and is arranging for the return of undispensed 1 oz. and 3 oz. from lot numbers associated with this recall.

• Consumers with questions regarding this recall can contact Blaine Labs, Inc. directly by using the contact information:

  • Phone: (800) 307-8818
  • Address: 11037 Lockport Pl, Santa Fe Springs, California, 90670
  • Email: Contact@blainelabs.com.

Health care professionals, consumers and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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