(NEW YORK) — 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.
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.
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.
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.”
ABC News has reached out to Taro Pharmaceuticals and its parent company Sun Pharma for comment.
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