Drug Safety Alerts

Sage Products Topical Skin Products Consumer-Level Recall

08/23/2016

On August 23, 2016, the United States Food and Drug Administration (FDA) issued a notice regarding a consumer-level recall notice regardingvarious topical skin products manufactured by Sage. This recall was issued due to potential product contamination with the bacteria, Burkholderia cepacia. Topical administration of a product with B. cepacia may cause serious infections in patients whose bodies cannot fight disease or in hospitalized patients, as well as certain other patient groups. These infections could be life-threatening. The recalled products were distributed to distributors, healthcare facilities and retailers in the United States, Canada, El Salvador, Singapore, Saudi Arabia, Portugal, the Netherlands, Malaysia, Mexico, Australia, Ireland, Honduras, United Kingdom, Denmark, Germany, Bahrain, and United Arab Emirates. The recalled products contain single-use, disposable cloths and were distributed between August 2014 and August 2016.

This recall affects the following products:

• Comfort Shield^® Barrier Cream Cloths
• Incontinence Clean-Up Cloth
• M-care^™ Meatal Cleansing Cloths for the Foley Catheterized Patient
• Comfort Bath^® Cleansing Washcloths
• 2% Chlorhexidine Gluconate Cloths

A complete list of the affected products and lot numbers is provided here:

Sage Products is notifying distributors, healthcare facilities, retailers and consumers by letter, and they are being provided instructions to discontinue use and return product to Sage Products.

Patients who received affected products should discontinue use of the affected products and return them to Sage Products for credit by contacting Sage Products customer service at 1‑800‑421-6556, Monday through Friday, 8:00 a.m. - 5:00 p.m. (CT). Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products.

Any adverse reactions or quality problems experienced with the use of these products maybe reported to the FDA.

CVS Caremark Response:

Please note: These products are not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, health care providers may contact Sage Products customer service at 1‑800‑421-6556, Monday through Friday, 8:00 a.m. - 5:00 p.m. (CT) or visit https://www.sageproducts.com/. You may also contact the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit http://www.fda.gov/.