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SafetyAlerts
December 13, 2001

Aloe Flex Enterprises Has Recalled "Weider's Eyedrops"

Dickinson, TX (SafetyAlerts) - The Food and Drug Administration (FDA) said that Aloe Flex Enterprise has recalled 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 this Class I 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, "Welder's Eyedrops".

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 Drug Administration
.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.