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X-Jow and Acne Shave Products by Shadow Holdings: Voluntary Recall - Due to Possible Bacterial Contamination

[Posted 05/29/2018]

AUDIENCE: Consumer

ISSUE: The products may be contaminated with bacteria. Topical administration of the products could result in potentially serious bacterial infections in immunocompromised individuals.

BACKGROUND: Herb-X Solutions X-Jow Pain Gel is used as an external analgesic and the United Exchange Acne Shave Moisturizer and Acne Shave Shave Cream with Acne Shield are used as topical acne medications. 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.

RECOMMENDATION: Consumers, distributors, and retailers that have the products, which are being recalled, should stop using and discard the products and can contact Shadow Holdings by calling 661-673-8519 Monday – Friday 8am – 5pm., Pacific Daylight Time (PDT). Consumers should contact their healthcare provider if they have experienced any problems that may be related to using this drug product.

Healthcare professionals 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: www.accessdata.fda.gov/scripts/medwatch/index.cfm

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

[05/25/2018 - Recall - FDA]

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