Major Pharmaceutical/Rugby Laboratories, based in Livonia, Mich., is recalling one lot of an anti-nausea drug because a distributor found it to be mislabeled as the drugmaker's schizophrenia drug.
The company is recalling lot number T04769, which might be in cartons labeled for dronabinol capsules 2.5 milligram — a drug for nausea and anorexia associated with weight loss in AIDS patients — or in packages labeled for ziprasidone hydrochloride capsules 20 milligram — a schizophrenia medication.
"There is a reasonable probability that patients who mistakenly take [dronabinol] instead of [ziprasidone] can experience serious adverse events from missing their ziprasidone dose and taking an unexpected dose of dronabinol," the FDA said June 14. "Patients missing doses of ziprasidone can experience exacerbation of underlying health issues such as bipolar disorder, schizophrenia, agitation, aggression or delirium. This can result in mental illness instability with possible consequences of self-harm or harm to others which could result in medical or psychiatric hospitalization."
No adverse events have been reported.