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J&J Risperdal recall

Johnson and Johnson's Ortho-McNeil-Janssen subsidiary has voluntarily recalled one unit each of schizophrenia drugs Risperdal and risperidone 2mg tablets following consumer reports of an 'uncharacteristic odour'

Johnson and Johnson's (J&J) Ortho-McNeil-Janssen subsidiary has voluntarily recalled one unit each of schizophrenia drugs Risperdal and risperidone 2mg tablets in the US following consumer reports of an 'uncharacteristic odour'.

The Risperdal lot includes 16,000 bottles, while the risperidone lot includes around 24,000 bottles.

The incident is the latest in a line of similar recalls from Ortho-McNeil stretching back to early 2010.

J&J said the odour is thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole), a by-product of a chemical preservative sometimes applied to wood often used in the construction of pallets on which materials are transported.

No serious adverse events have been reported following the use of Risperdal and risperidone in relation to TBA, although some patients have reported temporary gastrointestinal symptoms when taking other products with this odour.

J&J recommends patients to not stop taking their medication, and for anyone experiencing an uncharacteristic odour associated with either drug to return the tablets to their pharmacist, and contact their healthcare professional if they have questions. 

The recall comes a week after a safety announcement from the US Food and Drug Administration (FDA) alerting the public to medication error reports in which patients were given Risperdal instead of ropinirole (Requip: GlaxoSmithKline) and vice versa.

20th June 2011

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