Two Medications Recalled Due to Labeling Error, Posing Serious Concerns for Patient Safety and Well-being
Two medications have been recalled by the FDA due to a major mix-up, leading to potential serious adverse events. This means that the medication you have in your medicine cabinet may not be the correct prescription. The FDA is concerned about the recall and the possibility of severe adverse events.
Two Different Medications Are Being Recalled
According to a press release from the FDA on June 13, The Harvard Drug Group, LLC has voluntarily issued a recall for one lot of Dronabinol Capsules, USP, 2.5 mg, and one lot of Ziprasidone Hydrochloride Capsules, 20 mg. These medications were sold under the Major Pharmaceuticals brand and distributed to wholesalers across the country on April 5.
Dronabinol is typically used to treat anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS), as well as nausea and vomiting in patients undergoing cancer chemotherapy.
Ziprasidone Hydrochloride is used to treat mood and mental disorders like schizophrenia and bipolar disorder.
The labels on the medications were mixed up.
dronabinol label U.S. FDA The recall was initiated after a customer reported that some cartons labeled as Ziprasidone Hydrochloride actually contained blister packages labeled as and containing Dronabinol. In response to this mix-up, the FDA issued a warning to consumers, especially older adults who are taking other medications that affect mental function, as they are particularly at risk for adverse reactions.
The FDA stated, “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.”
Missing a dose of Ziprasidone can worsen underlying health issues, potentially leading to mental illness instability with the possibility of self-harm or harm to others, which may require medical or psychiatric hospitalization.
Taking an unknown dose of Dronabinol can impair mental and physical abilities, worsening symptoms in patients with mental illness disorders and limiting their ability to safely perform activities such as driving or operating machinery.
How to Identify the Recalled Products
If you are currently taking either of these medications, it is important to confirm that you have received the correct prescription. The recalled Dronabinol capsules were packaged in blister packages of 10 by 10, totaling 100 doses. The recalled Ziprasidone Hydrochloride capsules were packaged in blister packages of 10 by 4, totaling 40 doses. Both medications have the lot number T04769.
Ziprasidone Hydrochloride capsules can be identified by their “lavender opaque cap and flesh opaque body.” They also have “RDY” and “356” printed on either side. Dronabinol capsules are white and have “M2” printed on them.
Consumers should discontinue use of the recalled medications.
A woman suspiciously answering a phone call Shutterstock The Harvard Drug Group will notify affected accounts by mail and arrange for the collection of the recalled products. Wholesalers, distributors, and retailers have been instructed to cease distribution of these products.
The FDA advises consumers to stop taking the recalled medications, return them to the place of purchase, and contact their healthcare provider. For specific questions regarding the recall, Sedgwick, Inc. can be reached via email at [email protected] or by phone at 1-888-759-6904, Monday through Friday, between 8 a.m. and 5 p.m. Eastern Standard Time (EST).
Additionally, any adverse reactions should be reported through the FDA’s MedWatch Adverse Event Reporting program online, by mail, or by fax.
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