Ziprasidone Capsule
FDA Recall NDC 0904-6270
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Ziprasidone (NDC 0904-6270). A significant event, classified as Class I, was initiated on May 31, 2023 by Major Pharmaceuticals. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
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.
May 31, 2023
Jun 28, 2023
unknown
Recall Profile & Regulatory Data
Event ID
92463
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jul 02, 2024
Product Description
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
Batch or Lot Expiration Information
Lot# Lot: T04769 Exp. 2024/12
Affected Packages Involved in this Recall
0904-6269-08Product
0904-6269-45Product
0904-6270-08Product
0904-6270-45Product
0904-6271-08Product
0904-6271-45Product
0904-6272-08Product
0904-6272-45Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
