Los Angeles [California], March 21: The U.S. Food and Drug Administration (FDA) has recalled nearly 90,000 bottles of children's ibuprofen distributed nationwide, according to a recent enforcement report.
The agency said that 89,592 bottles of Taro Pharmaceuticals' Children's Ibuprofen Oral Suspension have been recalled due to the "presence of foreign substance."
The recall was initiated after the firm received complaints of a "gel-like mass" and "black particles" in the product.
The affected product -- USP, 100 mg per 5mL, in 4 FL OZ (120 mL) bottles -- was manufactured in India by Strides Pharma Inc. and distributed across the United States.
The recall involves lots 7261973A and 7261974A, with an expiration date of Jan. 31, 2027.
The FDA classified the action as a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, while the risk of serious harm is remote.
The recall is listed as voluntary and ongoing, with a recall initiation date of March 2.
Ibuprofen is a nonsteroidal anti-inflammatory drug that is used to relieve pain, fever, and inflammation.
Source: Xinhua News Agency
