Drug product

ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally-500 090 India, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-6269-08

D-0893-2023

May 31, 2023

Class I

Product summary

Firm: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Event: Event 92463
Status: Terminated
Classification: Class I
Quantity: unknown
Official record key: drug-enforcement:D-0893-2023

Official wording

Reason: Labeling: Label Mix-up: 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.

Code information: Lot: T04769 Exp. 2024/12

Distribution pattern: Nationwide in the USA

Derived failure modes

Labeling or packaging
reason.labeling_packaging · v1.0.0

Labeling: Label Mix-up