Moldy Antipsychotics Means Yet Another Recall For Johnson & Johnson

Psych Central reports that Johnson & Johnson recently initiated a product recall on two of the company’s anti-psychotic medications known as Risperdal and Risperidone. Physicians and mental health practitioners often prescribe these medications for a variety of mental health related ailments including autism, bipolar disorder and schizophrenia. A spokesperson from the subsidiary of Ortho-McNeil -Janssen Pharmaceuticals reports that the medications may have been contaminated with chemicals used to preserve wood pallets.

The recall came to light after consumers reported noticing an unusual musty or mold like odor upon opening the medication bottles. After examining the suspected products, researchers at Johnson & Johnson determined that the odor originated from trace chemicals referred to as TBA or 2,4,6 trbromoanisole. Manufacturers often treat wood products with a preservative that combines with airborne bacteria or mold to create the offensive byproduct. The wood is then commonly used in constructing the pallets that the company uses to transport pharmaceutical products.

Inspectors worked in cooperation with suppliers to find the source of the TBA. The investigation revealed that pallets found in a warehouse provided by a supplier contained the chemical compound. Researchers discovered that packaging materials created by the pharmaceutical company came into direct contact with the pallets, which transferred the substance to the inside of medication bottles.

While the odor is not considered harmful, consumer reports have included minor gastrointestinal symptoms after taking the medication from the affected containers. The company reports that consumers have not experienced any serious or health threatening effects related to the contamination. Johnson & Johnson reports that two lots in particular were affected by exposure to TBA and were shipped to pharmacies between 8/2010 and 01/2011.

The company is asking consumers to check Risperdal bottles containing 60-3mg. tablets having the lot number #0GG904 and an expiration date of 05/2012. The other lot affected concerns the Risperidone bottles containing 60-2mg. tablets with a lot number #OIG175 and an expiration date listed as 08/2012. If in possession of medication meeting these qualifications, Johnson & Johnson advises that patients should not abruptly stop taking the medication or adverse reactions may occur.

If bottles exhibit an unusual odor, return the container to your pharmacy and receive another prescription. Patients may also contact a healthcare provider if having any questions concerning TBA or the affected medications. For more detailed information about TBA, refer to http://datasheets.scbt.com/sc-238359.pdf. Studies indicate that since 2009, a number of healthcare and pharmaceutical company products have experienced contamination problems related to TBA.

http://psychcentral.com/news/2011/06/18/recall-of-antipsychotics-risperdal-risperidone-issued/27056.html
http://ramsey1.chem.uic.edu/chem232/page7/files/Tribromoanisole.pdf
http://www.pharmtech.com/pharmtech/article/articleDetail.jsp?id=787765