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FDA: Do Not Feed SimplyThick to Premature Infants
Date:5/20/2011

ve questions or concerns related to the use of the product and/or who have medical concerns should contact their health care provider.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program by:

  • Completing and submitting the adverse report online: www.fda.gov/MedWatch/report.htm
  • Downloading the pre-addressed, postage-paid FDA Form 3500 (or calling 1-800-332-1088 to request the form), completing it and faxing it to 1-800-FDA-0178; or
  • Mailing the completed form to MedWatch 5600 Fishers Lane, Rockville, MD 20857.

The information in this press release reflects the FDA's best efforts to communicate what it has learned from medical centers, the distributor and the state and local public health agencies involved in the investigation. The agency will update this page as more information becomes available.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


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SOURCE U.S. Food and Drug Administration
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