En Espanol (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm202956.htm)
SILVER SPRING, Md., March 3 /PRNewswire-HISPANIC PR WIRE/ — The U.S. Food and Drug Administration is warning consumers in Puerto Rico that two hand sanitizers — “Bee-Shield Hand Sanitizer” with Aloe Vera (10 fl. oz. or 1 gallon bottles) and “MD Quality Hand Sanitizer” with Aloe Vera (10 fl oz. bottles) — contain high levels of a bacteria, Burkholderia cepacia, that can cause serious infections in humans.
The products are manufactured by Puerto Rico Beverage Inc. of Maunabo, and distributed by Lord Pharmaceuticals LLC, Bee International Distributors, and Morales Distributors Inc. The hand sanitizers are distributed only in Puerto Rico.
Burkholderia can cause harm when hand sanitizers are used on skin with cuts or abrasions. Infections caused by the microbe that begin in the skin may progress farther into the body and require medical or surgical attention.
Although no adverse effects with these products have been reported to the FDA, the agency is recommending that consumers not use them and throw them away.
A recent FDA inspection of the Puerto Rico Beverage facility found serious problems in meeting the FDA’s current Good Manufacturing Practice requirements.
Consumers who have used these products and experienced adverse effects should contact a health care professional. Health care professionals and consumers may report serious adverse events or product quality problems to the FDA’s MedWatch Adverse Event Reporting program.
–Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
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SOURCE U.S. Food and Drug Administration