Label/Capsule Mix-Up Prompts Recall

The Harvard Drug Group, doing business as Major Pharmaceutical and Rugby Laboratories, is recalling a single lot of ziprasidone hydrochloride capsules and dronabinol capsules because of a product labeling mix-up.

According to the June 28, 2023, US Food and Drug Administration (FDA) Enforcement Report, unit dose cartons labeled as ziprasidone hydrochloride capsules, a drug used in the treatment of schizophrenia and bipolar disorder, were discovered to contain blister packages labeled as and containing dronabinol capsules. Dronabinol is used in the treatment of anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS) and in the treatment of nausea and vomiting associated with cancer chemotherapy.

“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,” the Harvard Drug Group stated in a June 13, 2023, company announcement.

The recall affects the following products, both of which are from lot T04769 (Exp 12/24):

• ziprasidone hydrochloride capsules, 20 mg, 40-capsule unit dose carton/10 x 4 blister packs (NDC 0904-6269-08), manufactured by Dr. Reddy’s Laboratories Limited, Bachupally, India, and distributed throughout the United States by Major Pharmaceuticals, Livonia, Michigan; and
• dronabinol capsules, 2.5 mg, 100-capsule unit dose carton/10 x 10 blister packs (NDC 0904-7144-61), manufactured by Patheon Softgels Inc, High Point, North Carolina, and distributed throughout the United States by Ascend Laboratories, Parsippany, New Jersey, and Major Pharmaceuticals. The capsules may be in outer cartons that read dronabinol capsules, USP, 2.5 mg, or ziprasidone hydrochloride capsules, 20 mg.

The Harvard Drug Group voluntarily initiated the recalls on June 5, 2023. The FDA has not yet classified them.