The FDA posted an online notice this month about a recall of Taro Pharmaceuticals’ Children’s Ibuprofen Oral Suspension, a children’s liquid pain reliever, after federal regulators said they received reports of contaminants in the product. The action covers nearly 90,000 bottles, according to the notice highlighted by the agency.
In the FDA notice, regulators said the recall began earlier this month after customers reported “a gel-like mass and black particles in the product.” The FDA also said the recall falls into a risk category in which the agency assessed that the risk of serious injury or health consequences to consumers is “remote,” meaning serious outcomes were not expected but the reported contamination warranted removal from the market.
Taro’s product information says the medication comes in a berry-flavored solution and is recommended for children ages 2 to 11. FDA’s notice ties the recall to specific reports from consumers about the physical condition of the liquid ibuprofen, rather than to a communication about dosing effectiveness.
The medication was manufactured in India by Strides Pharma Inc., the FDA notice said. The agency also said Strides initiated the recall, according to the notice, and the medication is part of Strides’ broader role producing generic and over-the-counter medicines for companies in the U.S. and elsewhere.
Neither Strides nor Taro Pharmaceuticals immediately responded to requests for comment Friday morning, the Associated Press reported. The FDA notice provides the regulatory basis for the recall while the companies awaited response.