An antipsychotic drug Risperdal and the generic Risperidone have been recalled after a strange odor had been reported by some patients taking the medication.
Ortho-McNeil-Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson (JNJ) on Thursday issued a recall of the drugs voluntarily after the report was taken. Around 16,000 bottles are being recalled.
The likely cause of musty moldy odor/taste is 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 bad smell.
The company had numerous recall incidents in the past 12 months including recall of Tylenol, Prezista, Topamax, Rolaids Extra Strength Softchews and more which have cost about $900 million in sales last year.
The drug is used to treat schizophrenia and bipolar disorder. The recall is said to include just 1 lot of the drugs that was shipped between Augutst 27, 2010 and February 15, 2011. The drug is also approved for the treatment of irritability in children with autism.
Below is information about the drug recalled:
Reisperdal (risperidone) Tablets - 3mg Bottles of 60 TabletsLot # 0GG904Expiration date - 05/2012
Risperidone Tablets - 2mg Bottles of 60 TabletsLot # OlG175Expiration date - 08/2012