About this recall:
The Harvard Drug Group is initiating a voluntary recall of a single lot of Dronabinol Capsules, USP, 2.5 mg and Ziprasidone Hydrochloride Capsules, 20 mg to the consumer level. The Harvard Drug Group received a customer complaint from a distributor, that some unit dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg for Lot T04769. Accordingly, The Harvard Drug Group is recalling all of Lot T04769, Dronabinol Capsules, USP, 2.5 mg, which may be in outer cartons that read Dronabinol Capsules, USP, 2.5 mg OR Ziprasidone Hydrochloride Capsules, 20 mg.
For lot recalls, the lot/batch information and expiration date for the recalled product can be viewed by clicking on the link to the FDA Recall Notification found below.
Ziprasidone Hydrochloride Capsules, 20 mg, is used for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder.
Dronabinol Capsules, USP, 2.5 mg, is used as: (1) an anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS), and (2) nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.
What this means to you:
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. Patients missing doses of Ziprasidone can experience exacerbation of underlying health issues such as bipolar disorder, schizophrenia, agitation, aggression, or delirium. 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. This can include worsening of symptoms in patients with mental illness disorders and limitation of patients’ abilities to safely complete hazardous activities (e.g., driving a motor vehicle, operating machinery).
Elderly patients or those taking other medications that affect mental function may be particularly at risk for these reactions. The Harvard Drug Group has not received any reports of adverse events related to this recall.
Consumers with questions regarding this recall can contact Sedgwick, Inc. by phone at 1‐888‐759‐6904 (8:00am‐ 5:00pm EST Monday through Friday) or by email address
harvarddrug6068@sedgwick.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
-
Complete and submit the report
online.
-
Regular Mail or Fax:
Download the form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA- 0178.
This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration.
FDA contact information for reporting adverse events/quality complaints can be reached
online or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.