Risperdal Recalled For Noxious Odor

Posted by BBC News on Jun 18th, 2011 and filed under Health Tips. You can follow any responses to this entry through the RSS 2.0. You can leave a response or trackback to this entry

Somewhere around 16,000 bottles of schizophrenia pharmaceutical – Risperdal – are already recalled by Johnson & Johnson company, Ortho-McNeil-Janssen Pharmaceuticals Inc. on account of an “uncharacteristic odor”.

The smell is assumed to be caused by traces of a byproduct of a chemical preservative which is placed on wooden pallets – 2, 4, 6 tribromoanisole (TBA). This company says TBA is not poisonous, but can give off an upsetting smell. A very small amount of patients may experience temporary gastrointestinal symptoms.

The company is recalling:
One lot of Risperdal (risperidone) 3 mg tablets advertised by Janssen Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
One lot of risperidone 2 mg tablets marketed by Patriot Pharmaceuticals, LLC, a wholly owned subsidiary of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Johnson & Johnson says it instituted several actions to minimize TBA contamination possibility.

The recalled Risperdal lot was delivered between 27th August 2010 and 15th February 2011. The corporation believes there are about 1,600 bottles of Risperdal from this lot still in the marketplace.

The recalled respiredone lot involves about 24,000 bottles and was shipped between 10th November, 2010 and 1st January, 2011. Fewer than 1,200 bottles are thought to still be in the marketplace.

Description of recalled merchandise:
RISPERDAL® (risperidone) Tablets 3mg Bottles of 60 Tablets
NDC Code – 50458-330-06. Lot Number – 0GG904. Expiry – May 2012
Risperidone Tablets 2mg Bottles of 60 Tablets
NDC Code – 50458-593-60. Lot Number – OlG175. Expiry – August 2012
Johnson & Johnson has had to announce several product recalls during the last couple of years of OTC and prescription drugs, as well as some medical devices. Experts repeat the company’s once pristine reputation has been severely affected.

Some product recalls over the final couple of years include: (Source: FDA)
1/14/11 – Tylenol® 8 Hour, Tylenol ® Arthritis Pain, and Tylenol ® upper respiratory products, and certain lots of Benadryl®, Sudafed PE®, and Sinutab® products.
12/9/10 – Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews, and Rolaids Multi-Symptom plus Anti-Gas Softchews.
11/29/10 – Mylanta and Alternagel Liquid Products.
11/27/2010 – Tylenol Cold Multi Symptom Daytime Liquid 8 oz Citrus Burst. Rolaids Extra Strength Softchews, Cherry Flavor, 36 count container. Jr Strength Motrin Caplets in 24 count packages. Children’s Benadryl Allergy FastMelt Tablets Cherry Flavor in 18 count containers.
10/18/2010 – Tylenol 8 hour Caplets in 50 count bottles.
5/28/10 – PediaCare Children’s Multi-Symptom Cold, Grape Flavor Liquid, 4 fl oz (118 mL). PediaCare Children’s Long-Acting Cough, Grape Flavor Liquid, 4 fl oz (118 mL). PediaCare Children’s Decongestant, Raspberry Flavor Liquid, 4 fl oz (118 mL). PediaCare Children’s Allergy & Cold, Grape Flavor Liquid, 4 fl oz (118 mL)

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