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About 90,000 bottles of children’s ibuprofen have been recalled due to the presence of a foreign substance, according to the Food and Drug Administration.
Strides Pharma, Inc., headquartered in India, has recalled about 89,592 bottles of its 100-milligram Ibuprofen Oral Suspension, the FDA said. The affected product was manufactured for Taro Pharmaceuticals USA and distributed throughout the US
Ibuprofen was sold in 4-fluid-ounce bottles of 100 milligrams by 5 milliliters.
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About 90,000 bottles of children’s ibuprofen have been recalled. (Getty Images / Getty Images)
The packages include lottery numbers 7261973A and 7261974A, with an expiration date of Jan. 31, 2027.
The recall was issued earlier this month after complaints of a gel-like mass and black particles in the product.
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The affected product was manufactured for Taro Pharmaceuticals USA and distributed throughout the US (iStock / Stock)
But the FDA revised the classification this week to a Phase II recall, which means “use or exposure to the offending product may cause temporary or reversible health effects or where the likelihood of adverse health effects is remote.”
A phase II classification is the FDA’s second level of urgency.
A phase II classification is the FDA’s second level of urgency. (Stefani Reynolds/Bloomberg via Getty Images/Getty Images)
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Consumers who have purchased the recalled ibuprofen are urged to stop using it immediately.
Parents who are concerned after their child has consumed the product should consult a health care provider.
