Risperidone recall by J&J

Ortho-McNeil-Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson, recalled about 16,000 bottles of its Risperdal schizophrenia drug on reports of an uncharacteristic odor. The recall affects one lot that was shipped between Aug. 27, 2010, and Feb. 15, 2011.

Specific recalls include;

  • Risperdal Tablets 3 mg – Bottles of 60 tablets – NDC Code 50458-330-06 – Lot Number 0GG904 – Expiry May 2012
  • Risperidone Tablets 3 mg – Bottles of 60 tablets – NDC Code 50458-593-60 – Lot Number OlG175 – Expiry August 2012

It is thought to contain trace amounts of 2, 4, 6 tribromoanisole, or TBA, the byproduct of a chemical preservative sometimes applied to wooden pallets. Although it isn't considered toxic, TBA can generate an offensive odor, the company said. A very small number of patients have reported temporary gastrointestinal symptoms when taking other products with this odor.

Risperdal is used for the treatment of schizophrenia in adults and adolescents ages 13 – 17 years. Risperidone is used alone or in combination with other medicines 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. It is also used for the treatment of irritability associated with autistic disorder in children and adolescents ages 5 – 16 years.

Dr. Ananya Mandal

Written by

Dr. Ananya Mandal

Dr. Ananya Mandal is a doctor by profession, lecturer by vocation and a medical writer by passion. She specialized in Clinical Pharmacology after her bachelor's (MBBS). For her, health communication is not just writing complicated reviews for professionals but making medical knowledge understandable and available to the general public as well.

Citations

Please use one of the following formats to cite this article in your essay, paper or report:

  • APA

    Mandal, Ananya. (2018, August 23). Risperidone recall by J&J. News-Medical. Retrieved on October 25, 2021 from https://www.news-medical.net/news/20110619/Risperidone-recall-by-JJ.aspx.

  • MLA

    Mandal, Ananya. "Risperidone recall by J&J". News-Medical. 25 October 2021. <https://www.news-medical.net/news/20110619/Risperidone-recall-by-JJ.aspx>.

  • Chicago

    Mandal, Ananya. "Risperidone recall by J&J". News-Medical. https://www.news-medical.net/news/20110619/Risperidone-recall-by-JJ.aspx. (accessed October 25, 2021).

  • Harvard

    Mandal, Ananya. 2018. Risperidone recall by J&J. News-Medical, viewed 25 October 2021, https://www.news-medical.net/news/20110619/Risperidone-recall-by-JJ.aspx.

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
You might also like... ×
Telehealth to the rescue for children’s mental health during COVID