FDA recall D-0893-2023

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Class I · 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

Reason for recall

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.

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2023-05-31
Report date: 2023-06-28
Termination date: 2024-07-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: La Vergne, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0893-2023