Class Action Litigation Blog

Ortho-McNeil-Janssen Pharmaceuticals, Inc. Voluntarily Recalls Lot of RISPERDAL® Tablets and Risperidone Tablets

Patients suffering injury from unsafe pharmaceuticals  need to be properly treated medically for all adverse conditions that developed and fairly compensated for any financial loss, national class action product liability attorney Keith T. Belt says

Ortho-McNeil-Janssen Pharmaceuticals, Inc. has initiating a voluntary recall of one lot of RISPERDAL® (risperidone) 3mg Tablets, marketed by Janssen Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and one lot of risperidone 2mg Tablets, marketed by Patriot Pharmaceuticals, LLC, a wholly owned subsidiary of Ortho-McNeil-Janssen Pharmaceuticals, Inc. The recalls stem from two consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole).

TBA is a byproduct of a chemical preservative sometimes applied to wood often used in the construction of pallets on which materials are
transported and stored. In January 2010, the company instituted a number of actions to reduce the potential of TBA contamination, including requiring suppliers to certify that they do not use pallets made from chemically-treated wood.

While not considered to be toxic, TBA can generate an offensive odor and a very small number of patients have reported temporary
gastrointestinal symptoms when taking other products with this odor. As it relates to RISPERDAL® and risperidone, there have been no reported serious adverse events caused by the presence of TBA.

The RISPERDAL® lot – which includes approximately 16,000 bottles – was shipped between 8/27/2010 and 2/15/2011. The company believes there are approximately 1,600 bottles of RISPERDAL® from this lot remaining in the marketplace. The risperidone lot – which includes approximately 24,000 bottles – was shipped between 11/10/2010 and 1/01/2011. The company believes there are fewer than 1,200 bottles of risperidone from this lot remaining in the marketplace.

RISPERDAL® (risperidone) is used for the treatment of schizophrenia in adults and adolescents ages 13-17 years.

RISPERDAL® (risperidone) is used alone or in combination with other medicines (valproate or lithium) in adults for the short-term treatment of bipolar mania; or alone in adults, children and adolescents ages 10-17 years for the short-term treatment of bipolar mania.

RISPERDAL® (risperidone) is used for the treatment of irritability associated with autistic disorder in children and adolescents ages 5-16
years.

Ortho-McNeil-Janssen Pharmaceuticals, Inc. has initiated these recalls in the U.S. and Puerto Rico at the wholesale and retail (pharmacy) level and is communicating this information to these customers. The company does not anticipate a product shortage resulting from this action.

Patients should not stop taking their medication. Anyone experiencing an uncharacteristic odor associated with RISPERDAL® 3mg Tablets or risperidone 2mg Tablets should return the tablets to their pharmacist, and contact their healthcare professional if they have questions. Patients or healthcare professionals can contact the Medical Information Recall Line at 1-800-634-8977 (Monday – Friday, 9 am – 5 pm ET).
Information can also be found on http://www.risperdal.com/¹ , http://www.fda.gov/Safety/Recalls/ucm259820.htm and http://www.patriotpharmaceuticals.com/².

About Belt Law Firm, P.C.

Belt Law Firm, P.C., has more than 70 years of combined experience, and has the resources and experience to take on class action lawsuits of any size and against any opponent. In the past, our class action lawyers have participated in several large-scale class and mass joiner actions and have secured millions of dollars for our clients. Class-action lawsuits are an efficient and calculated way to take on large, well-represented organizations, and also to help the maximum number of people.  Class action lawsuits offer a number of advantages because they are able to aggregate a large number of what are often smaller individualized claims into one class action lawsuit. Our class action attorneys’ main mission is to bring powerful representation and justice to the individual or small business. In the process, class actions provide the necessary impetus to change laws for the better and to help thousands of people who have been injured, oppressed or have suffered injustice.  We put our reputation on the line in every case.

If you believe that you have been cheated or defrauded by a common corporate plan or scheme, you should contact us immediately at Belt Law Firm by filling out this form or by calling us toll free at 1-888-933-1514 for your Free Class Action Consultation

Back to Top