Perrigo recalls oral drops for children in U.S.
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Perrigo Co. voluntarily recalled four types of liquid pain, cough and cold drops packaged with syringes that could make it difficult to measure proper doses for young children, the company and regulators said on Monday.
Perrigo said the recall would cost the company about $2 million.
The recalled products are Cherry Flavor Infant Pain Reliever 160 mg Acetaminophen (0.5 oz. and 1.0 oz.), Grape Flavor Infant Pain Reliever 160 mg Acetaminophen (0.5 oz. and 1.0 oz.), Cherry Flavor Cough and Cold Infant Drops (0.5 oz.) and Cherry Flavor Decongestant and Cough Infant Drops (0.5 oz.).
The oral syringes distributed with the over-the-counter medicines were not marked to measure doses less than 1.6 milliliter, which may be prescribed for children younger than 2 and less than 24 pounds, the Food and Drug Administration said in a statement.
Ingesting too much acetaminophen, a pain-relieving ingredient, may cause liver damage, the FDA said.
The products were distributed nationally at retail chains under 34 different store-brand labels including CVS, Target Corp. and Walgreen Co., the FDA said.
Until recently, the pain relievers had been distributed with droppers that had different markings, the FDA said.
The change and the new markings “caused some confusion among consumers and health-care professionals and may lead to improper dosing,” the FDA said.
Perrigo, in a filing with securities regulators, said the value of its on-hand inventories and the cost of return and disposal are estimated to be about $2 million and will be recorded in the fiscal 2005 fourth quarter that ended June 25.
Shares of Allegan, Michigan-based Perrigo gained 7 cents to close at $13.97 on Nasdaq.
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