By Michael L. Diamond, Asbury Park Press, N.J.
A Johnson & Johnson subsidiary has recalled two lots of the antipsychotic drug Risperdal after consumers complained about a strange odor, the company said.
Ortho-McNeil-Janssen Pharmaceuticals Inc. officials said they traced the odor to a chemical that was applied to wood pallets used by a suppliers of packaging material.
New Brunswick-based Johnson & Johnson has about 114,000 employees, including 14,000 in New Jersey. Risperdal is made by its Janssen division, based in Hopewell.
The drug has been approved by the Food and Drug Administration to treat schizophrenia and bipolar mania, although it has been used by doctors to treat other diseases, such as Alzheimer's.
The odor is thought to be caused by a byproduct of a chemical preservative sometimes applied to wood. Another Johnson & Johnson subsidiary, McNeil Consumer Healthcare, in January recalled dozens of products, including several types of Tylenol and Motrin, because of an odor caused by the same chemical.
Ortho-McNeil-Janssen on Friday recalled about 16,000 bottles that were manufactured at its plant in Gurabo, Puerto Rico, and sent to pharmacies and wholesalers nationwide, spokesman Mark Wolfe said.
The company said the odor can cause temporary gastrointestinal symptoms, but no serious side effects. It said patients should not stop taking their medication. But they should return the tablets to their pharmacist if they detect an unusual odor.
Wolfe said the company in 2010 revamped procedures to protect itself against contamination.
One way: Require suppliers to use heat-treated, instead of chemically treated, wood pallets.
Asked how these pallets made it to the manufacturing site, Wolfe said the company's investigation is ongoing.
[ McClatchy-Tribune Information Services • 2011-06-21 ]