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Published on May 03, 2010 by Edgar Snyder

McNeil Knew About Contamination, FDA Says

Children's medicine recalled

May 05 2010 UPDATE – The Food and Drug Administration (FDA) is reporting that McNeil Consumer Healthcare knowingly used bacteria-contaminated materials to make recently recalled children's medications.

McNeil recalled 1,500 lots of children's and infants' Tylenol, Motrin, Zyrtec and Benadryl last week. The company has since suspended operations at the plant where the medications were manufactured.

FDA officials said so far no batches of the final product have proven to be contaminated. The agency also announced that further investigation is needed to decide if further action, including fines, is warranted.

Children's Tylenol and Other Medications Recalled

May 03 2010 ORIGINAL ALERT – Consumers should stop using certain over-the-counter children's drugs due to manufacturing deficiencies, according to the Food and Drug Administration (FDA). A recall has been announced for more than 40 common medications, including Tylenol and Motrin.

A unit of Johnson & Johnson, McNeil Consumer Healthcare, implemented the recall because the deficiencies may affect the potency, purity or quality of the products, said the FDA. The recall includes all unexpired lots of seven products in 43 different flavors and sizes. Among them are Tylenol Infants' Drops, Children's Tylenol Suspensions, Infants' Motrin Drops, Children's Benadryl Allergy liquids, and Children's Zyrtec liquids in bottles. McNeil has a full list of the recalled lots on a special recall website.

Consumers are advised to stop using certain lots of infants' and children's Tylenol, Motrin, Zyrtec, and Benadryl because some of them may contain an excess amount of the active drug ingredient. The other products included in the recall may contain foreign particles or inactive ingredients that may not meet testing requirements, McNeil said.

This recall comes after McNeil was cited last Friday for manufacturing violations found during a routine inspection at their plant, an FDA spokeswoman said. This is the second major recall this year for McNeil. A January recall included several hundred lots of adult and children’s products due to reports of moldy smells coming from over-the-counter medicines made at a plant in Puerto Rico.

Sources: "Children's Tylenol and Other Drugs Recalled." The New York Times. May 1, 2010.
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