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Schizophrenia, nausea drugs recalled after labeling mix-up

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LA VERGNE, Tenn. (WRIC) – The Harvard Drug Group has recalled a single lot of the drugs Dronabinol and Ziprasidone Hydrochloride after labels on the two drugs were mixed up.

During the distribution process, it was discovered that cartons labeled as Ziprasidone Hydrochloride actually contained packages labeled as and containing Dronabinol, according to the Food and Drug Administration.

Ziprasidone Hydrochloride is used for the treatment of schizophrenia and bipolar disorder, while Dronabinol is frequently used to treat nausea, vomiting and loss of appetite in chemotherapy and AIDS patients.

Patients who mistakenly take a dose of Dronabinol instead of Ziprasidone Hydrochloride can experience worsening symptoms of bipolar disorder and schizophrenia, including agitation, aggression, delirium and self-harm. Older people may be “particularly at risk.”

“Taking an unexpected dose of Dronabinol may cause mental and cognitive effects that result in impairment of mental and/or physical abilities,” the FDA stated. “This can include worsening of symptoms in patients with mental illness disorders and limitation of patients’ abilities to safely complete hazardous activities.”

The Harvard Drug Group specifically recalled all 2.5mg Dronabinol Capsules and all 20 mg Ziprasidone Hydrochloride Capsules labeled with Lot T04769.

The group has not received any reports of patients experiencing adverse symptoms related to the recall, the FDA said.

Anyone with questions about the recall can contact Sedgwick, Inc. by phone at 1-888-759-6904 or by email address harvarddrug6068@sedgwick.com.

Patients should contact their doctor or healthcare provider if they have experienced any problems that may be related to taking Dronabinol or Ziprasidone Hydrochloride.

Recalls and Consumer Alerts

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