Recall Enforment Report D-0767-2022

Recall Details

Drug Recall Enforcement Report Class I voluntary initiated by Jubilant Cadista Pharmaceuticals, Inc., originally initiated on 03-08-2022 for the product Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801, NDC 59746-122-06 The product was recalled due to labeling: label mix-up: incorrect label placed on product. shipper cases labeled meclizine hydrochloride tablets contain bottles incorrectly labeled as prednisone tablets. the tablets in the bottles are meclizine hydrochloride. The product was distributed in Product Was Distributed In Arkansas, Florida, North Carolina, South Carolina And Ohio. and the recall is currently terminated.

Field Name Field Value
Event ID 89854 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-0767-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern Product was distributed in Arkansas, Florida, North Carolina, South Carolina and Ohio. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801, NDC 59746-122-06
Reason For Recall Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 12,174 bottles Product Quantity
The amount of product subject to recall.
Voluntary Mandated Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date 04-06-2022
Recall Initiation Date 03-08-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Termination Date 11-15-2022 What is the Date Terminated?
The date that FDA terminated the recall.
Initial Firm Notification E-Mail Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type Drugs
Recalling Firm Jubilant Cadista Pharmaceuticals, Inc.
Code Info Lot # 22P0036, Exp 12/2024 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages 59746-122-06; 59746-122-10; 59746-121-06; 59746-121-10
Status Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
59746-121Meclizine Hydrochloride Meclizine HydroclorideTabletOralJubilant Cadista Pharmacuticals Inc.Human Prescription Drug
59746-122Meclizine Hydrochloride Meclizine HydrochlorideTabletOralJubilant Cadista Pharmacuticals Inc.Human Prescription Drug