Alzheimer's Blogging:
Have you read Alzheimer's Weekly yet this week? There is an interesting treatment article called
risperdal recall. I have copy and pasted it for you to read. This was the drug of choice for my father in law while he was still alive.
TITUSVILLE, N.J., /PRNewswire/ -- Ortho-McNeil-Janssen Pharmaceuticals, Inc. is initiating a voluntary recall of one lot of RISPERDAL® (risperidone) 3mg Tablets, marketed by Janssen Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and one lot of risperidone 2mg Tablets, marketed by Patriot Pharmaceuticals, LLC, a wholly owned subsidiary of Ortho-McNeil-Janssen Pharmaceuticals, Inc. The recalls stem from two consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole).
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. In
January 2010, the company instituted a number of actions to reduce the potential of TBA contamination, including requiring suppliers to certify that they do not use pallets made from chemically-treated wood.
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 RISPERDAL® lot – which includes approximately 16,000 bottles – was shipped
between 8/27/2010 and 2/15/2011. The company believes there are approximately 1,600 bottles of RISPERDAL® from this lot remaining in the marketplace. The risperidone lot – which includes approximately 24,000 bottles – was shipped
between 11/10/2010 and 1/01/2011. The company believes there are fewer than 1,200 bottles of risperidone from this lot remaining in the marketplace.
Package Description | NDC Code | Lot Number | Expiry | |
RISPERDAL® (risperidone)
Tablets 3mg Bottles of 60 Tablets | 50458-330-06 | 0GG904 | May 2012 | |
Risperidone Tablets
2mg Bottles of 60 Tablets | 50458-593-60 | OlG175 | August 2012 | |
| | | | |
RISPERDAL® (risperidone) is used for the treatment of schizophrenia in adults and adolescents ages 13-17 years.
RISPERDAL® (risperidone) is used alone or in combination with other medicines (valproate or lithium) 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.
RISPERDAL® (risperidone) is used for the treatment of irritability associated with autistic disorder in children and adolescents ages 5-16 years.
Ortho-McNeil-Janssen Pharmaceuticals, Inc. has initiated these recalls in the U.S. and
Puerto Rico at the wholesale and retail (pharmacy) level and is communicating this information to these customers. The company does not anticipate a product shortage resulting from this action.
Patients should not stop taking their medication. 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 – Friday,
9 am –
5 pm ET). Information can also be found on
http://www.risperdal.com/ and
http://www.patriotpharmaceuticals.com/
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program online, or through regular mail or by fax.
We 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 our suppliers in its warehouse were contaminated with TBA. In addition, some of the packaging components manufactured by our supplier were exposed to these pallets. We have initiated a deeper investigation to determine the potential impact of these findings to other products. 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.
RISPERDAL® 3mg Tablets are yellow and imprinted with "JANSSEN" on one side and R3 on the other. Risperidone 2mg Tablets are orange and imprinted "PATR" on one side and R2 on the other. Fos
Sincerely,
Marie Fostino
Alzheimer's A Caretakers Journal
Seaboard Press An Imprint of James A Rock Pub., Co.
http://www.mariefostino.com/
http://www.mariefostino.blogspot.com/
