Recall of Antipsychotics Risperdal, Risperidone Issued

[Guest guest]

http://psychcentral.com/news/2011/06/18/recall-of-antipsychotics-risperdal-rispe\

ridone-issued/27056.html

Recall of Antipsychotics Risperdal, Risperidone Issued

By Psych Central News Editor

Reviewed by M. Grohol, Psy.D. on June 18, 2011

Two popular antipsychotic medications made by & — 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 & -owned subsidiary Ortho-McNeil-Janssen

Pharmaceuticals.

The recall was prompted by reports from two consumers of an odd odor emanating

from their medication. & tracked the odor down to trace amounts

of TBA (2,4,6 tribromoanisole).

According to & , 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.

The antipsychotic drug is commonly used to treat schizophrenia and bipolar mania

in teens and adults, and the treatment of irritability associated with autistic

disorder in children and teens.

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).

& 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- (Monday – Friday, 9 am – 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 & , they conducted an

investigation involving our 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 & supplier were exposed

to these pallets.

" We have initiated a deeper investigation to determine the potential impact of

these findings to other products, " noted a spokesperson for & .

" 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: &

[Guest guest]

That seems strange. How could that have happened.

In a message dated 6/18/2011 12:23:38 P.M. Eastern Daylight Time, no_reply writes:

Recall of Antipsychotics Risperdal, Risperidone Issued