Recall announced for dronabinol, ziprasidone hydrochloride capsules due to mislabeling

Dronabinol, ziprasidone hydrochloride recall overview: 

• Who: The Harvard Drug Group recalled lots of dronabinol capsules and ziprasidone hydrochloride capsules.
• Why: The dronabinol capsules may be packaged with the ziprasidone hydrochloride label.
• Where: The dronabinol and ziprasidone hydrochloride recall is active in the United States.

The Harvard Drug Group announced a recall for packages of dronabinol medication as they may be packaged in cartons labeled as ziprasidone hydrochloride, potentially leading to serious adverse effects for those who rely on the medication.

The U.S. Food & Drug Administration (FDA) website published the recall June 14. It applies to Lot T04769 of Dronabinol capsules, USP, 2.5 mg, which may be in outer cartons that read dronabinol capsules, USP, 2.5 mg, or ziprasidone hydrochloride Capsules, 20 mg.  The capsules are sold under the brand “Major,” according to the recall.

Ziprasidone hydrochloride is used for the treatment of schizophrenia, the treatment of bipolar manic or mixed episodes, and for the maintenance treatment of bipolar disorder, the recall states. Dronabinol, on the other hand, is used to treat anorexia associated with weight loss in patients with AIDS and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

As a result, there is a reasonable probability that patients who mistakenly take dronabinol instead of ziprasidone hydrochloride can experience “serious adverse events,” the recall says.

“Patients missing doses of ziprasidone can experience exacerbation of underlying health issues such as bipolar disorder, schizophrenia, agitation, aggression or delirium,” the dronabinol and ziprasidone hydrochloride recall states.“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.”

Elderly patients or those taking other medications that affect mental function may be particularly at risk for these reactions, the recall says. 

The Harvard Drug Group has not received any reports of adverse events related to the recall so far. The company is not currently facing legal action over the recall, but Top Class Actions follows recalls closely as they sometimes end in class action lawsuits.

Stop using product, contact doctor, dronabinol and ziprasidone hydrochloride recall advises

The Harvard Drug Group initiated the recall after it received a customer complaint that some cartons labeled as ziprasidone hydrochloride contained blister packages containing dronabinol. It distributed the medication nationwide to wholesalers starting April 5, 2023.

Consumers with the recalled product should stop using it, return it to the place of purchase and contact their physician or health care provider, the company says.

Pharmaceutical companies often announce recalls for medication. In March, Ascent Laboratories LLC issued a recall for certain packages of its 75 mg and 150 mg capsules of the anticoagulant dabigatran etexilate.

Are you affected by the dronabinol and ziprasidone hydrochloride recall? Let us know in the comments! 

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