New York Times
By NATASHA SINGER
Published: May 1, 2010
A unit of Johnson & Johnson has voluntarily begun a recall of certain children’s over-the-counter liquid medicines because of manufacturing deficiencies, the FDA said on Saturday.
The deficiencies may affect the potency, purity or quality of the products, the agency said in a statement. It said it was investigating the plant where the products were made to make sure there were no other problems.
Consumers should stop using certain lots of infants’ and children’s Tylenol, Motrin, Zyrtec and Benadryl products because some of them may contain more of the active drug ingredient than specified, the Johnson & Johnson unit, McNeil Consumer Healthcare, said in a statement late Friday. Other products involved in the recall may contain foreign particles or inactive ingredients that may not meet testing requirements, the company said.
“The particles may be solidified product ingredients or manufacturing residue such as tiny metal specks,” Marc Boston, a McNeil spokesman, said.
McNeil did not undertake the recall because of adverse health reactions to the products, the company said, but it advised consumers to stop using them.
Although the potential for serious medical problems is remote, McNeil said, parents and caregivers should not give the products to children.
The recall involves all unexpired lots of seven products in 43 different flavors and sizes. These include Tylenol Infants’ Drops, Children’s Tylenol Suspensions, Infants’ Motrin Drops, Children’s Zyrtec liquids in bottles and Children’s Benadryl Allergy liquids.
McNeil has posted a full list of the recalled product lots on a dedicated Web site: mcneilproductrecall.com. The recall comes after federal health regulators cited McNeil on Friday morning for manufacturing violations found during a routine inspection at a company facility in Fort Washington, Pa., an F.D.A. spokeswoman said. This is the second major recall this year for McNeil. In January, after receiving reports of moldy smells emanating from over-the-counter medicines made at a plant in Puerto Rico, the company recalled several hundred lots of adult and children’s products. The earlier recall involved certain lots of Benadryl, Motrin, Rolaids, Simply Sleep, St. Joseph Aspirin and Tylenol.
McNeil has a hotline, (888) 222-6036
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(888) 222-6036
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, available 8 a.m. to 10 p.m. Eastern time, Monday through Friday and on weekends from 9 a.m. to 5 p.m. But due to high call volumes, a reporter who called the hotline at different times on Saturday was unable to reach a customer service representative. A recorded message directed callers to the company’s Web site and later disconnected. McNeil said it was working to respond to the high call volumes.