Industry

Drug recall: Dronabinol Capsules, Ziprasidone HCL Capsules recalled due to this reason

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (USFDA).

July 14, 2023

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Last Updated on October 10, 2024 by The Health Master

The Harvard Drug Group, LLC d/b/a Major Pharmaceutical and Rugby Laboratories is initiating a voluntary recall of a single lot of Dronabinol Capsules, USP, 2.5 mg and Ziprasidone Hydrochloride Capsules, 20 mg to the consumer level.

The Harvard Drug Group, LLC 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, The Harvard Drug Group, LLC is recalling 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.

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Risk Statement: There is a reasonable probability that patients who mistakenly take Dronabinol Capsules, USP, 2.5 mg instead of Ziprasidone Hydrochloride, 20 mg capsules, can experience serious adverse events from:

1) missing their ziprasidone dose and
2) 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.

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 (e.g., driving a motor vehicle, operating machinery).

Elderly patients or those taking other medications that affect mental function may be particularly at risk for these reactions. The Harvard Drug Group, LLC has not received any reports of adverse events related to this recall.

Ziprasidone Hydrochloride Capsules, 20 mg, 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 Capsules, USP, 2.5 mg, is used as:

(1) an 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 to respond adequately to conventional antiemetic treatments.

Both Ziprasidone Hydrochloride Capsules, 20 mg and Dronabinol Capsules, USP, 2.5 mg are labeled with lot T04769 EXP. 2024/12 and can be identified on the outer carton labeling as follows:

Product Name	Package Description	Brand Name	Lot Number	NDC	Expiration Date
Dronabinol Capsules, USP, 2.5 mg	100 Unit Doses per Carton (10 x 10 blister packs)	Major	T04769	0904-7144-61	2024/12
Ziprasidone Hydrochloride Capsules, 20 mg	40 Unit Doses per Carton (10 x 4 blister packs)	Major	T04769	0904-6269-08	2024/12