Harvard Drug Group, which operates as big pharmaceutical company and the Rugby Institute have recalled a number of two medicines that may have been mispackaged.
Recovered were dronabinol capsules 2.5 mg and ziprasidone hydrochloride capsules 20 mg. Announcement from the US Food and Drug Administration.
The FDA said it had received complaints from customers that drugs labeled as ziprasidone hydrochloride actually contained dronabinol.
The FDA says ziprasione hydrochloride is used to treat schizophrenia.
Dronabinol is used to treat “anorexia associated with weight loss in patients with acquired immunodeficiency syndrome and (2) nausea and vomiting associated with cancer chemotherapy in patients who have not responded adequately to conventional antiemetic therapy.” will be
The FDA said patients taking dronabinol instead of ziprasidone have a “reasonable probability” of experiencing a “cascade of adverse events” from missed doses of ziprasidone and unexpected doses of dronabinol.
The FDA said 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.
Ingesting unexpected amounts of dronabinol can cause mental and cognitive effects leading to impaired mental and/or physical performance.
This may include exacerbation of symptoms in people with mental illness or limiting their 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. ”
Details of the recalled medications are as follows:
- dronabinol capsules, 2.5 mg, 100 servings per carton in blister packs, lot number T04769, NDC 0904-7144-61, expiration date December 2024. The capsule is white and stamped “M2”.
- ziprasidone hydrochloride capsules, 20 mg, in blister packs, 40 doses per carton, lot number T04769, NDC 0904-6269-08, expiration date December 2024. The capsule has a lavender colored opaque cap and a flesh colored opaque body with “RDY” printed on the cap. 356 inches is printed on the body.
The drug was distributed nationwide from April 5, 2023.
For more information, please contact Sedgwick at 888-759-6904 Monday through Friday, 8:00 a.m. to 5:00 p.m. Eastern Time. Or send an email to [email protected].
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