Taro Pharmaceuticals, a subsidiary of India drugmaker Sun Pharmaceutical, issued a recall of nearly 37,000 bottles of grape-flavored loratadine syrup, an antihistamine used to treat allergy symptoms in children.
According to the FDA, Taro is recalling 36,684 bottles of Children's Loratadine Syrup manufactured in the company's facility in Hawthorne, NY, after "blue plastic" was found floating in the product. The nationwide recall was issued by the company in December, the agency said in an enforcement report.
Late last week, Sun reported Q3 net income fell 7% to 14.3 billion rupees ($230 million), with revenues in the U.S., which accounted for nearly 60% of its total, of $413 million, off by 5% from the same quarter last year. Taro, which is 60% owned by Sun, reported gains for the quarter.
Israeli-based Taro said its net profit rose 22.4% for the third quarter ended Dec. 14, up $142 million from $116 million for the same period last year. Net sales were $238 million for the quarter, a gain of 11.2% from $214 million.
Most of Taro's business is focused on the U.S. market.
- see the FDA report