Nearly 90,000 bottles of children’s ibuprofen are being voluntarily recalled due to the potential presence of a foreign substance.
According to a notice from the Food and Drug Administration, Taro Pharmaceuticals U.S.A., Inc. received complaints from customers who reported “a gel-like mass and black particles” in the drug products.
NIH – PHOTO: Bottles of children’s ibuprofen, made for Taro Pharmaceuticals U.S.A., Inc., are being recalled due to the potential presence of a foreign substance.
Four-ounce (120 ml) bottles of Children’s Ibuprofen Oral Suspension are impacted by the recall. The FDA said the children’s medications, intended for pain relief from the common cold, flu, sore throat, headache and toothache and a fever reducer, were manufactured in India for Taro Pharmaceuticals U.S.A., Inc.
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Recalled children’s ibuprofen products have lot codes of: 7261973A and 7261974A and bear an expiration date of 01/31/2027, according to the federal agency.
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The FDA is classifying the recall as a Class II, which the agency defines as anything where the “use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Taro Pharmaceuticals is a subsidiary of Sun Pharma.
In a statement, Jeremy Allen, vice president of corporate affairs for Sun Pharma, said: “We are committed to maintaining the highest standards of quality across all Taro labeled products, including those manufactured by third-party partners such as Strides, the application holder. We are in close contact with Strides as it fully investigates the root cause of this issue and ensures all regulatory expectations are met. Sun Pharmaceuticals remains dedicated to protecting patient safety and ensuring strong oversight of our partner.”
