McNeil Consumer Healthcare, a division of Johnson & Johnson, said it is expanding its recall of 21 lots of over the counter medications. The recall was initiated January 15.
The expanded recall was triggered by consumer complaints of a musty, moldy odor.
The recall includes some Children's Tylenol as well as adult-strength Benadryl, Motrin IB, Tylenol Extra Strength, Tylenol Day & Night and Tylenol PM.
The company's problems first came to light last December, when McNeil recalled all lots of Tylenol Arthritis Pain 100 count with EZ-OPEN CAP related to this issue. Then in January it expanded the recall to include a number of children's medicines.
The recall followed an investigation of reports from consumer 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 that included nausea, stomach pain, vomiting, or diarrhea.
At the time McNeil Consumer Healthcare said the strange 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, the company said.
In late April the Food and Drug Administration (FDA) urged consumers to stop using Children's Tylenol and McNeil's other over-the-counter products. In early May the agency explained why.
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.
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, which owns McNeil Consumer Healthcare, suspended production at the Pennsylvania plant and promised to do better.
