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SimplyThick Recalled, Linked to Serious Illness in Infants

By Kelly Balamuth on July 19, 2011

The U.S. Food and Drug Administration (FDA) is alerting parents, caregivers, and healthcare providers that a product called SimplyThick is being recalled by the manufacturer. SimplyThick is a thickening gel designed to help people who suffer from dysphagia, or trouble swallowing. The product is used to help those who have sustained a throat trauma to swallow liquids more easily. It is also used in breast milk and infant formula given to premature babies who have difficulty swallowing. It also helps them keep down the milk and helps prevent spitting up. However, the FDA has recently been made aware of 15 cases of necrotizing enterocolitis (NEC) in premature babies who were given SimplyThick. NEC is a condition in which tissue in the intestines becomes inflamed and dies. The FDA continues to investigate the link between the babies with NEC and SimplytThick; however, it is believed that product made in the company’s Stone Mountain, GA, plant contained harmful bacteria.

The FDA is recommending that parents and medical staff should not feed SimplyThick to premature infants born before 37 weeks gestation. The FDA also urges parents to contact a health care professional immediately if their baby has a bloated stomach, greenish-tinged vomiting, or bloody stools. Cases in which babies exhibit side effects related to SimplyThick should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

If you or a loved one has been injured or made ill by an unsafe product, call the Orinda defective product lawyers at Balamuth Harrington. Our experienced attorneys know how to get you the best possible outcome for your case. In fact, we obtained a settlement of up to $400,000 for a client against a medical manufacturer. Our lawyers can help you too. Call today for a free consultation at 1-888-254-1234.

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Attorney Kelly Balamuth was profiled in the
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