Risperdal Recalled by Manufacturer Due to Drug Contamination

Our Talbot County, Maryland pharmacy error injury lawyer blog recently discussed a series of recalls drug maker Johnson & Johnson made last year, in an effort to maintain the health and safety of consumers—after complaints of an unusual smell causing nausea, vomiting, diarrhea and gastrointestinal pain were reported, due to trace amounts of 2, 4, and 6-tribomoanisole (TBA), a chemical used to preserve wood necessary in the construction of pallets used for transportation and shipping of the product packaging materials.

In related news, Ortho-McNeil-Janssen Pharmaceutical, the drug manufactures of Risperdal (risperidone), an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and irritability associated with autistic disorder in adolescents and children, recently voluntarily recalled 16,000 bottles of the brand name drug and 24,000 bottles of the generic drug—also because of an unusual odor.

The Risperdal drug manufacturers found that the unusual smell was also caused by trace amounts of TBA, used to preserve wood pallets for the transportation and storage of product materials. While not considered to be toxic, a small group of patients have reported gastrointestinal symptoms when taking products with this offensive odor. The drug maker claims that the presence of TBA has not caused any reported serious adverse events, but the company has instituted a series of actions to reduce the potential of TBA contamination in the future, to avoid personal injury or harm to any consumers.

This is the second medication error warning surrounding Risperdal this year. Last month our attorneys discussed another warning involving Risperdal in a Baltimore pharmacy error injury blog, issued by the U.S. Food and Drug Administration, discussing potentially dangerous medication errors associated with Risperdal and Requip, a drug used for the treatment of Parkinson’s disease and Restless Legs Syndrome, with 226 reports of patients receiving the incorrect medication.

In the State of Maryland, contact our attorneys a Lebowitz and Mzhen, LLC today for a free consultation about your rights.

Ortho-McNeil-Janssen Pharmaceuticals, Inc. Voluntarily Recalls One Lot of RISPERDAL® Tablets and One Lot of Risperidone Tablets, U.S. Department of Food and Drug Administration (FDA), June 17, 2011
Risperidone Recalled Due to Possible Contamination, Medscape Today, June 20, 2011
FDA Drug Safety Communication: Medication errors resulting from confusion between risperidone (Risperdal) and ropinirole (Requip), U.S. Food and Drug Administration, June 13, 2011
FDA Warns of Drug Name Mix-Ups, Medpage Today, June 15, 2011

Related Web Resources:

U.S. Food and Drug Administration: Medication Error Reports

Institute for Safe Medication Practices, (ISMP)

Related Blog Posts:

FDA Warns of Confusion between Risperdal and Requip, Leading to Medication Error, Pharmacy Error Injury Lawyer Blog, June 27, 2011
FDA Tips for Administering OTC Medication to Children—to Reduce Medication Error Injury, Pharmacy Error Injury Lawyer Blog, June 6, 2011
FDA Panel Looks to Prevent Drug Error by Changing Children’s Acetaminophen Product Labels, Pharmacy Error Injury Lawyer Blog, May 27, 2011
FDA Redesigns Pharmacy Packet Inserts to Avoid Medication Error Injury, Pharmacy Error Injury Lawyer Blog, May 9, 2011
FDA Pressures Johnson & Johnson for Broad Recall of OTC Drugs, Pharmacy Error Injury Lawyer Blog, January 25, 2010

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