McNeil Consumer Healthcare, a unit of Johnson & Johnson, has recalled more children's over-the-counter products. As in recalls earlier this year, the products in question were produced at the company's Fort Washington, Pa., plant.
The recall includes nearly five million packages of Motrin, Rolaids and Benadryl to address quality control issues.
"This is a wholesale and retail level recall and is not being undertaken on the basis of adverse events," the company said in a statement. "No action is required by consumers or healthcare providers and consumers can continue to use the product."
Included in the recall are Children's Benadryl Allergy Fastmelt Tablets in cherry and grape. The drug was distributed in both the U.S. and other countries.
The recall was issued after a review by the parent company "revealed insufficiencies in the development of the manufacturing process." The Rolaids recall was initiated based on consumer complaints about the texture of the tablets.
In late 2009 and early 2010 the company launched a recall of products, including Tylenol, Benadryl, Motrin and Rolaids. The recall followed an investigation of reports from consumers of an unusual moldy, musty, or mildew-like odor that -- in a small number of cases -- was associated with temporary and non-serious gastrointestinal events.
Based on this investigation, McNeil Consumer Healthcare reported in January that the uncharacteristic smell was caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). This can result from the breakdown of a chemical that is sometimes applied to wood that is used to build wood pallets that transport and store product packaging materials.
In early May the Food and DrugAdministration (FDA) urged consumers to stop using Children's Tylenol and other over-the-counter products made by McNeil Consumer Healthcare.FDA said its inspectors encountered thick dust and contaminated ingredients at the Fort Washington, Pa., plant producing the products. Some equipment was covered with grime, there was a hole in the ceiling in one room and pipes were patched with duct tape, the report said.
On closer inspection, FDA said it found raw ingredients contaminated by an unspecified bacteria, a lack of quality control procedures and poor handling of complaints. Among the complaints, the agency said, were 46 reports of "dark material" in the liquid products between June 2009 and April 2010. While bacteria were present in the plant, FDA said its tests failed to detect it in any finished product.
Johnson & Johnson suspended production at the Pennsylvania plant and promised to do better.
"The quality issues that the FDA has observed, many of which we had recently identified in our own quality reviews and communicated to the FDA, are unacceptable to us, and not indicative of how McNeil Consumer Healthcare intends to operate," the company said in a May 2010 statement. "
In regard to the latest recall, Johnson & Johnson saidConsumers with questions should call the company's Consumer Care Center at 1-888-222-6036 (available Monday-Friday from 8 a.m. - 8 p.m. ET and Saturday - Sunday, 9 a.m. - 5 p.m. Eastern Time.)
Johnson & Johnson has recalled more over-the-counter medicine produced at a Pennsylvania plant....