December 13, 2001Aloe Flex Enterprises Has Recalled
Dickinson, TX (SafetyAlerts)
- The Food and Drug Administration (FDA) said that Aloe Flex Enterprise
all lots of its 1 ounce bottles of "Weider's Eyedrops" due to potentially
serious health risks associated with bacterial contamination. Samples
analyzed by the Food and Drug Administration were found to contain bacteria
including Acinetobacter calcoaceticus-baumannii, which in some cases can
cause sight-threatening injury.
This is the first public notice of
recall issued by the FDA.
The product is labeled
"Weider's Eyedrops" with the company name of "Flex Enterprises". Some lots
of the product have also been marketed under the a second brand name,
The recalled "Weider's Eyedrops" and "Welder's Eyedrops" were sold
over-the-counter in Dickinson, Texas.
To date, there have been no reports of injury in connection with these
products. Individuals who have used these products and have experienced any
adverse reactions are advised to contact their healthcare provider.
Consumers who have purchased "Weider's Eyedrops" or "Welder's Eyedrops" are
urged to return them to the place of purchase for a full refund. Consumers
with questions may contact the company at 281-337-2240.
Any adverse reactions experienced with the use of this product should also
be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax
at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane,
Rockville, MD 20852-9787, or on the MedWatch web site at www.fda.gov/medwatch/index.html.
This voluntary recall is being conducted with the knowledge of the Food and