Dronabinol Capsules 2.5mg, Ziprasidone Hydrochloride Capsules 20mg Recalled

Harvard Drug Group, LLC d/b/a Major Pharmaceutical and Rugby Laboratories is recalling a single lot of Dronabinol Capsules, USP, 2.5 mg and Ziprasidone Hydrochloride Capsules, 20 mg. The packaging may contain incorrect product due to labeling mix-up, the U.S. Food and Drug Administration said.

The recall was initiated after the La Vergne, Tennessee-based company received a customer complaint from a distributor, that some unit dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg for Lot T04769.

Accordingly, Harvard Drug is calling back all of Lot T04769, 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.

Both Ziprasidone Hydrochloride Capsules, 20 mg and Dronabinol Capsules, USP, 2.5 mg are labeled with lot T04769 EXP. 2024/12. Ziprasidone Hydrochloride Capsules, 20 mg are capsules with a lavender opaque cap and flesh opaque body. Dronabinol Capsules, USP, 2.5 mg are white capsules.

The products were distributed Nationwide to wholesalers starting April 5, 2023.

Ziprasidone is used for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder.

Dronabinol is used as an anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome or AIDS, and Nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

The agency noted that patients who mistakenly take Dronabinol Capsules, USP, 2.5 mg instead of Ziprasidone Hydrochloride, 20 mg capsules, are likely to experience serious adverse events from missing their ziprasidone dose and taking an unexpected dose of Dronabinol.

Patients missing doses of Ziprasidone can experience exacerbation of underlying health issues such as bipolar disorder, schizophrenia, agitation, aggression, or delirium.

Further, taking an unexpected dose of Dronabinol may cause mental and cognitive effects that result in impairment of mental and/or physical abilities.

However, Harvard Drug has not received any reports of adverse events related to the recall to date.

Wholesalers, distributors and retailers are asked to stop distribution of the product and consumers are asked to stop using the affected product, and return it to the place of purchase. They are also asked to contact their physician or healthcare provider.

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