Topical shave creams, acne products and pain gels manufactured by Shadow Holdings are being recalled because they may be contaminated with bacteria that could lead to serious infections in people with compromised immune systems. To date, no reports of adverse events have been associated with use of these products.
Affected products include all lots within expiration date of Herb-X Solutions X-Jow Pain Gel, and United Exchange Acne Shave Moisturizer, Acne Shave Shave Cream with Acne Shield, and Acne Shave Shave Kit.
Herb-X Solutions X-Jow Pain Gel is an external analgesic, and is packaged in 4 oz. and 8 oz. bottles. The United Exchange Acne Shave Moisturizer and Acne Shave Shave Cream with Acne Shield are used as topical acne medicines and are packaged in 3.3 oz. and 5.1 oz. bottles, respectively. The United Exchange Acne Shave Shave Kit contains potentially affected units of both the Acne Shave Moisturizer and the Acne Shave Shave Cream with Acne Shield.
Consumers with questions about the recall can contact Shadow Holdings at 661-673-8519. Anyone who has used these products and experienced any problems should contact their doctor. Any adverse events should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
The recall comes a week after the Food and Drug Administration warned consumers not to use Medline Remedy Essentials No-Rinse Cleansing Foam manufactured by Shadow Holdings, doing business as Bocci Laboratories, because the products may be contaminated with several species within the bacteria Burkholder cepacia complex (Bcc) and pose risks to patients with compromised immune systems. The company later recalled the products.
As of May 2018, the Centers for Disease Control and Prevention (CDC) confirmed 10 cases of Bcc linked to use of the cleansing foam. The patients were already hospitalized for acute conditions and acquired the infections while in the hospital.
FDA Recall Notice
Center for Infectious Disease Research and Policy