Risperdal Recalled Due To Strange Smell

Approximately 16,000 bottles of schizophrenia drug -Risperdal - have been recalled by Johnson & Johnson company, Ortho-McNeil-Janssen Pharmaceuticals Inc. because of an"uncharacteristic odor".

The smell is thought to be caused by traces of a byproduct of a chemical preservative which is applied to wooden pallets - 2, 4, 6 tribromoanisole (TBA). The company says TBA is not toxic, but can give off an unpleasant smell. A very small number of patients may experience temporary gastrointestinal symptoms.

The company is recalling:

• One lot of Risperdal (risperidone) 3 mg tablets marketed 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 reduce TBA contamination risk.

The recalled Risperdal lot was shipped between 27th August 2010 and 15th February 2011. The company 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 products:

• 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 over the last couple of years of OTC and prescription medications, as well as some medical devices. Experts say the company's once pristine reputation has been severely affected.

Some product recalls over the last 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)