Risperdal Recalled For Odor

Ortho-McNeil-Janssen Pharmaceuticals Inc., a division of the beleaguered drug giant Johnson & Johnson, just issued a recall of its antipsychotic medication, <"http://www.yourlawyer.com/topics/overview/risperdal">Risperdal, and Risperdal’s generic version; both over an odor believed to be linked to a chemical preservative used in wood shipping pallets, said The Associated Press (AP). This recall is just one of many in a seemingly endless going series of Johnson & Johnson recalls on which we have written.

Ortho-McNeil-Janssen said patients should not stop taking their medications, but if an uncharacteristic odor is noticed, patients should return the tablets to their pharmacy and refer questions to their healthcare professional, said the AP, which noted that both Risperdal and risperidone are used in the treatment of schizophrenia in adults and teenagers and can also be used as a short-term bipolar mania treatment.

Risperdal has been known to cause irregular heartbeats, muscle weakness and spasms, high fever, constipation, weight gain, and headaches. Risperdal has also been linked to diabetes, Neuroleptic Malignant Syndrome (NMS), Stroke, and Tardive Dyskinesia. There have been 37 reports of stroke or stroke-like events, including 16 deaths linked to Risperdal.

According to Johnson & Johnson’s Ortho-McNeil-Janssen, the recalled lot included 16,000 bottles of Risperdal in 3-milligram tablets that were shipped between August 2010 and February, said the AP. Some 1,600 bottles remain on the market.

The recall also involves a lot of 24,000 bottles of the 2-milligram generic risperidone tablets, said the AP. That lot was shipped between November 2010 and January 1; the drug maker believes less than 1,200 bottles of the recalled lot are still on the market, said the AP, which noted that Ortho-McNeil-Janssen said the recall is limited to the United States and Puerto Rico.

In March, we wrote that Johnson & Johnson’s McNeil Consumer Healthcare unit issued another recall of musty-smelling Tylenol that involved 134,000 150-count bottles of Tylenol 8-Hour Extended Release Caplets. That recall also had to do with tribromoanisole (TBA), as well as 2,4,6-trichloroanisole (TCA).

TBA has been behind other recalls of musty-smelling Tylenol in the past. For instance, in March we wrote about another Johnson & Johnson recalled medication manufactured in its Puerto Rico plant. The March recall had to do with 11,700 bottles of its HIV/AIDS medication, Prezista, in a number of countries following complaints of the drug releasing an offensive odor. At the time, Johnson & Johnson said it had taken steps to minimize TBA contamination that involved mandating its suppliers confirm that TBA pallets are not used.

Johnson & Johnson has, since September 2009, announced at least two dozen recalls involving over 300 million bottles of nonprescription medicines as well as prescription medications, contact lenses, and over 90,000 hip replacement devices, noted the AP. Recalls have been called for reasons that range, said the AP, the gamut from “nauseating odors and incorrect levels of active ingredient to contaminants in medicines and uncomfortable hip replacements requiring repeat surgery.”

This entry was posted in Pharmaceuticals. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.