Silver Spring, Maryland—(ENEWSPF)—May 29, 2018
By: Rosemary Piser
The Food and Drug Administration (FDA) has announced that Shadow Holdings is voluntarily recalling all lots, within expiry, 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 to the retail level. The products may be contaminated with bacteria.
Topical administration of the products could result in potentially serious bacterial infections in immuno-compromised individuals. To date, Shadow Holdings has not received any reports of adverse events related to this recall.
Herb-X Solutions X-Jow Pain Gel, used as an external analgesic, 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 medications, 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.
|Herb-X Solutions||X-Jow Pain Gel, 4oz.|
|X-Jow Pain Gel, 8oz.|
|United Exchange||Acne Shave Moisturizer, 3.3 oz.|
|Acne Shave Shave Cream with Acne Shield, 5.1 oz.|
|Acne Shave Shave Kit|
The products were distributed nationwide to retail and wholesale outlets.
Shadow Holdings is notifying its distributors and customers by written notification. Consumers, distributors, and retailers that have the products, which are being recalled, should stop using and discard the products.
Consumers with questions regarding this recall can contact Shadow Holdings by calling 661-673-8519 Monday – Friday 8am – 5pm., Pacific Daylight Time (PDT). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form fda.gov/MedWatch/getforms.htm 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
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.