WASHINGTON, D.C. — Tris Pharma, Inc., headquartered in Monmouth, New Jersey, announced a voluntary recall of its Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25mL. Some of the lots of the medication the company distributed contain higher amounts of Ibuprofen than intended. Ibuprofen in higher doses is harmful to children and could lead to permanent injuries, especially to a child’s kidneys, according to an article appearing on 13 WOWK. Tris Pharma distributed the recalled Ibuprofen to larger retail outlets across the U.S. and sold as store brands in CVS, Wal-Mart, and Family Dollar Services, Inc.
The U.S. Food and Drug Administration (FDA) said six lots of Tris Pharma, Inc.’s baby oral solution Ibuprofen need to be recalled out of an abundance of caution. The Ibuprofen oral solution recalled could contain as much as ten percent more Ibuprofen than the packaging indicates. Some infants have a higher sensitivity to Ibuprofen than others. Consequently, receiving a dose that is more potent than the prescribed dose could cause a severe injury to a child’s renal system. Based upon that information Tris Pharma recalled Lot Number 4718 marketed as a CVS store brand; Lot number 00717009A, sold as Wal-Mart’s store brand Equate; Lot number 0071715A also marketed under the Equate banner at Wal-Mart; and Lot number 00717024A marketed as Equate at Wal-Mart, CVS Health at CVS, and Family Wellness sold at Family Dollar Services, Inc.
The FDA also said that Tris Pharma, Inc. is unaware of any serious side effects from children receiving high-than-prescribed doses of Ibuprofen. The FDA cautioned parents that scientific studies have shown toxicity is a problem in young children when they receive doses that exceed 700% of the recommended amount of medication. Tris Pharma, Inc. asked its customers to cease the distribution of the affected lots and has arranged for its distributors to return the recalled products. Additionally, parents should call their child’s pediatrician if the child experiences any adverse effects after taking Ibuprofen.
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