A voluntary recall has been issued after boxes that were labeled for a drug used for mental health patients contained instead blister packets of a drug used to help patients dealing with AIDS or cancer treatments, according to the U.S. Food and Drug Administration.
Major Pharmaceutical and Rugby Laboratories recalled one lot each of Ziprasidone Hydrochloride, 20 mg strength, and Dronabinol capsules, 2.5 mg strength.
Because of a packaging error, the blister packs of Dronabinol were inside the boxes labeled for Ziprasidone, although the blister packs were labeled as containing Dronabinol.
According to WebMD, Ziprasidone treats schizophrenia, “bipolar manic or mixed episodes and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder.”
Dronabinol is used to treat the “anorexia associated with weight loss” in AIDS patients or nausea and vomiting that comes with chemotherapy treatments.
“Patients missing doses of Ziprasidone can experience exacerbation of underlying health issues such as bipolar disorder, schizophrenia, agitation, aggression, or delirium,” the recall notice says.
The Harvard Drug Group Recalls Dronabinol Capsules and Ziprasidone Hydrochloride Capsuleshttps://t.co/GSj0Fs5xNg
— Recall Insider (@Recallinsider) June 14, 2023
Both Ziprasidone Hydrochloride Capsules, 20 mg and Dronabinol Capsules, USP, 2.5 mg are labeled with lot T04769 EXP. 2024/12 pic.twitter.com/z8tYToWqiP
“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.”
The recalled drugs both have lot No. T04769 with a December 2024 expiration date.
Ziprasidone 20 mg capsules have a lavender opaque cap with “RDY” on it and “356″ on the capsules’ body. Dronabinol capsules are white with “M2.” on them.
You should stop using the medication, the FDA says.
If you have any questions about this recall, call Sedgwick, Inc. at 888-759-6904, Monday through Friday, 8 a.m. to 5 p.m., EDT time; or email harvarddrug6068@sedgwick.com.
Sedgwick is handling the recall for the Harvard Group,
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