India’s Strides Pharma has issued a voluntary recall for 89,592 bottles of children's ibuprofen oral suspension in the U.S. following reports of contamination.
The product, which was produced by Strides in India for Taro Pharmaceuticals' U.S. subsidiary, was recalled after complaints to the company flagged a “a gel-like mass and black particles” in the product, the FDA said in a posting on its website.
The recall is ranked as Class II, which the U.S. regulator uses for recalled products that could cause temporary, medically reversible health consequences if used or where the probability of serious, irreversible adverse health effects is remote.
The recalled product is widely sold in the U.S. as Children’s Motrin.
The lots under recall are 7261973A and 7261974A, both with an expiration date of January 2027. The recalled pain reliever was distributed across the U.S., according to the FDA notice.
To date, there have been no reports of adverse health incidents related to the recall.
The product pull, which was initiated by Strides on March 2, follows news (PDF) from the company that its Singapore subsidiary received FDA approval in late January to manufacture acetaminophen and ibuprofen tablets at Strides’ main production facility in Bengaluru, India.