STATEN ISLAND, NY Two drugs have been recalled due to a major labeling mix-up, according to a recall notice from the U.S. Food and Drug Administration (FDA).
The Harvard Drug Group, which includes Major Pharmaceutical and Rugby Laboratories, is initiating a voluntary single-lot recall of Dronabinol Capsules, USP, 2.5 mg and Ziprasidone Hydrochloride Capsules, 20 mg at the consumer level. The recall comes after the company received a consumer complaint from a distributor that some unit-dose cartons labeled Ziprasidone Hydrochloride Capsules, 20 mg contained blister packs labeled as and containing Dronabinol Capsules, USP, 2.5 mg for lot T04769.
Due to the confusion, Harvard Drug Group is recalling all lot T04769, Dronabinol Capsules, USP, 2.5 mg, which may be in outer packaging labeled Dronabinol Capsules, USP, 2.5 mg OR Ziprasidone Hydrochloride Capsules, 20 mg .
Ziprasidone Hydrochloride Capsule, 20 mg, is used for the treatment of schizophrenia, as monotherapy for the acute treatment of manic or mixed bipolar episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder.
Dronabinol Capsules, USP, 2.5 mg, is used as: (1) anorexia associated with weight loss in patients with acquired immune deficiency syndrome (AIDS), and (2) nausea and vomiting associated with cancer chemotherapy in patients who have failed adequately to traditional antiemetic treatments.
According to the FDA, there is a reasonable likelihood that patients who mistakenly take Dronabinol capsules instead of Ziprasidone hydrochloride could experience serious adverse events due to missing ziprasidone dose and taking an unexpected dose of dronabinol.
Patients who miss doses of ziprasidone may experience exacerbation of underlying health problems 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. And taking an unexpected dose of dronabinol can cause mental and cognitive effects that result in impaired mental and/or physical abilities. This may include worsening symptoms in patients with mental disorders and limiting patients’ ability to safely complete hazardous tasks (eg, driving a motor vehicle, operating machinery). Elderly patients or those taking other drugs that affect mental function may be at particular risk for these reactions.
The Harvard Drug Group has not received any adverse event reports related to this recall.
The products were distributed nationwide to wholesalers starting April 5, 2023.
The Harvard Drug Group is notifying all affected direct accounts by mail of this voluntary recall and is arranging for the return of all recalled products listed above. Wholesalers, distributors, and retailers who have affected product that is being recalled should stop distributing the product, and consumers should stop using this affected product, return it to the place of purchase, and contact their physician or healthcare professional.
Consumers with questions regarding this recall may contact Sedgwick, Inc. by phone at 1-888-759-6904 or by email firstname.lastname@example.org. Consumers should contact their physician or healthcare professional if they experience any problems that may be related to taking or using this pharmaceutical product.
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