Boxes labeled as mental health meds actually had drugs for AIDS and cancer patients
Boxes labeled for a drug used for mental health patients actually had blister packets of a drug used to help patients dealing with AIDS or cancer treatments.
The Harvard Group aka Major Pharmaceutical and Rugby Labatories recalled one lot each of Ziprasidone Hydrochloride, 20 mg strength, and Dronabinol capsules, 2.5 mg strength. The blister packs of Dronabinol were inside the boxes labeled for Ziprasidone, although the blister packs were labeled as containing Dronabinol.
Ziprasidone, the company-written, FDA-posted recall notice says, treats schizophrenia, “bipolar manic or mixed episodes and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder.”
Dronabinol, the company says, is used to treat the “anorexia associated with weight loss” in AIDS patients or the 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. “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.”
Both recalled drugs 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. They were sent to wholesalers on April 5.
If you have either capsules as a wholesaler, distributor or retailer, stop selling them. If you’re a consumer, return them to the pharmacy or medical professional from which you got them. If you have any questions about this recall, call Sedgwick, Inc., which is handling the recall for the Harvard Group, at 888-759-6904, Monday through Friday, 8 a.m. to 5 p.m., Eastern time or email harvarddrug6068@sedgwick.com.
If you have had any medical problems from this or any other drug, see a medical professional. Then, let the FDA know via its MedWatch Adverse Event page or by filling out a form you can get by calling 800-332-1088.
