Labeling Mix up Leads to Recall of Dronabinol and Ziprasidone

Major Pharmaceutical is initiating a voluntary recall of a single lot of dronabinol capsules, 2.5 mg and ziprasidone hydrochloride capsules 20 mg. Some unit dose cartons labeled as ziprasidone hydrochloride capsules were found to contain blister packages labeled as and containing dronabinol capsules.

Ziprasidone is used to treat patients with schizophrenia and bipolar disorder. Dronabinol is used to treat patients with anorexia in those with AIDS, as well to treat nausea and vomiting associated with cancer chemotherapy.

Patients missing doses of ziprasidone can experience exacerbation of underlying health issues. 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. Taking an unexpected dose of dronabinol may cause mental and cognitive effects that result in impairment of mental and/or physical abilities. This can include worsening of symptoms in patients with mental illness disorders and limitation of patients’ abilities to safely complete hazardous activities.

The company has not received any reports of adverse events.

Both ziprasidone and dronabinol capsules are labeled with lot T04769 with an expiration date of December 2024. The NDC number for ziprasidone 0904-6269-08 and the NDC number for dronabinol is 0904-7144-61.