Two popular antipsychotic medications made by Johnson & Johnson — Risperdal and risperidone — have been recalled due to possible contamination with a chemical used to treat the wood pallets the drug is often transported on.
The drug is from the Johnson & Johnson-owned subsidiary Ortho-McNeil-Janssen Pharmaceuticals.
The recall was prompted by reports from two consumers of an odd odor emanating from their medication. Johnson & Johnson tracked the odor down to trace amounts of TBA (2,4,6 tribromoanisole).
According to Johnson & Johnson, 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.
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.
Two lots are affected by the recall. The Risperdal lot was shipped to pharmacies between 8/27/2010 and 2/15/2011 and the risperidone lot was shipped to pharmacies between 11/10/2010 and 1/01/2011. The recalls are for Risperdal tablets 3mg, Bottles of 60 Tablets (Lot #0GG904, expiration 5/2012) and risperidone tablets 2mg, Bottles of 60 Tablets (Lot #OlG175, expiration 8/2012).
Johnson & Johnson warns that patients should not stop taking their medication.
Instead, 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 â€“ Friday, 9 am â€“ 5 pm ET). Information can also be found on www.risperdal.com and www.patriotpharmaceuticals.com.
Investigation Into the Contamination
According to information supplied by Johnson & Johnson, they conducted an investigation involving suppliers to evaluate the potential source of this TBA issue.
This investigation revealed that some of the wooden pallets used by one of their suppliers in its warehouse were contaminated with TBA. In addition, some of the packaging components manufactured by the Johnson & Johnson supplier were exposed to these pallets.
“We have initiated a deeper investigation to determine the potential impact of these findings to other products,” said a spokesperson for Johnson & Johnson.
“We also are working with peer companies to better understand how and where TBA is entering and impacting our supply chains and what we can do to further mitigate this exposure. The voluntary recall, being implemented with the knowledge of the U.S. Food and Drug Administration (FDA), was initiated after enhanced surveillance and complaint monitoring programs escalated two odor-related reports.”
Source: Johnson & Johnson