STATEN ISLAND, N.Y. — Two medicines will be recalled due to major label mix-ups, according to the agency’s recall alert. U.S. Food and Drug Administration (FDA).
The Harvard University Drug Group, which includes the major pharmaceutical labs and the Rugby Institute, has initiated a voluntary consumer-level recall of single lots of dronabinol capsules (USP) 2.5mg and ziprasidone hydrochloride capsules (20mg). The recall states that some unit dose cartons labeled Ziprasidone Hydrochloride Capsules 20 mg were found to contain blister packages labeled Dronabinol Capsules USP 2.5 mg, Lot T04769. It was done after the company received a consumer complaint from a distributor.
Because of this mix-up, Harvard Drug Group is recalling all Lot T04769, Dronabinol Capsules, USP, 2.5 mg. These outer boxes may say Dronabinol Capsules, USP, 2.5 mg, or Ziprasidone Hydrochloride Capsules, 20 mg.
Ziprasidone Hydrochloride Capsules 20 mg is used for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar mania or mixed episodes, and as an adjunct to lithium or valproate for maintenance treatment of bipolar disorder. will be
Dronabinol Capsules, USP, 2.5 mg has been used for (1) anorexia associated with weight loss in patients with acquired immunodeficiency syndrome (AIDS) and (2) nausea and vomiting associated with cancer chemotherapy in failed patients. will be used. Suitable for conventional antiemetic therapy.
According to the FDA, patients who mistakenly take dronabinol capsules instead of ziprasidone hydrochloride may experience serious adverse events from forgetting a dose of ziprasidone or taking an unexpected dose of dronabinol. is quite likely.
Patients who miss a dose of ziprasidone may experience worsening of underlying medical conditions such as bipolar disorder, schizophrenia, agitation, aggression, and delirium. As a result, mental illness can become unstable, leading to self-harm and harm to others, and may require admission to a medical or psychiatric facility. Also, taking unexpected amounts of dronabinol can cause mental and cognitive effects that lead to impaired mental and/or physical performance. This may include exacerbation of symptoms in patients with mental illness and limitations in the patient’s ability to safely complete hazardous activities (such as driving a car or operating machinery). Older patients and those taking other drugs that affect mental function may be particularly at risk of these reactions.
Harvard Drug Group has not received any reports of adverse events related to this recall.
From April 5, 2023, products were distributed to wholesalers nationwide.
Harvard Drug Group has mailed all affected direct accounts of this voluntary recall and is arranging the return of all recalled products described above. Wholesalers, distributors, and retailers of recalled products should discontinue distribution of the products, and consumers should stop using the affected products, return them to the place of purchase, and contact their physician or health care provider. is needed.
Consumers with questions regarding this recall may contact Sedgwick, Inc. at 1-888-759-6904 or email. [email protected]. Consumers should contact their doctor or health care provider if they experience any problems that may be related to the intake or use of this medicine.
