Prescription Drug Recall: Ziprasidone Cartons Contain Wrong Medication
Unit Dose cartons labeled as Ziprasidone Hydrochloride 20 mg were found to contain Dronabinol 2.5 mg instead. Lot T04769 (Exp. 2024/12) was distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall. Per the rubric, FDA Class I recalls score at minimum 4 (Severe). The recall involves a serious medication mix-up where patients could receive a completely different prescription drug, presenting significant patient safety risk.
Plain-English summary
Ziprasidone Hydrochloride Capsules 20 mg in Unit Dose cartons, manufactured by Dr. Reddy's Laboratories Limited and distributed by Major Pharmaceuticals and Rugby Laboratories, are being recalled due to a labeling and packaging error.
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. This mix-up could result in patients receiving an entirely different prescription medication than what was prescribed to them.
The affected lot is T04769, expiring December 2024 (Exp. 2024/12). The product was distributed nationwide in the USA. The recall affects multiple NDC packages: 0904-6269-08, 0904-6270-08, 0904-6271-08, and 0904-6272-08.
Patients or healthcare providers who have Unit Dose cartons of Ziprasidone from this lot should stop using the product immediately and contact their pharmacy or prescribing healthcare provider. The medication must not be used.
The recalled product
- Product
- ZIPRASIDONE (ZIPRASIDONE)
- Brand
- ZIPRASIDONE
- Manufacturer
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Hazard
- label-mix-up
- medication-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: T04769 Exp. 2024/12
Distribution
Distributed nationwide across the United States.
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