Recall Enforment Report D-0096-2023

Drug Recall Enforcement Report Class III voluntary initiated by Jubilant Cadista Pharmaceuticals, Inc., originally initiated on 12-27-2022 for the product Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06 The product was recalled due to subpotent drug: out of specification for assay at the 18-month stability timepoint.. The product was distributed nationwide and the recall is currently ongoing.

Field Name Field Value
Event ID 91412 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-0096-2023 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 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 Nationwide in the USA. 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 Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06
Reason For Recall Subpotent Drug: Out of specification for assay at the 18-month stability timepoint. What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 14,061 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 01-11-2023
Recall Initiation Date 12-27-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification Letter 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#: 21P0336, Exp: 04/2023 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 59746-113-06; 59746-113-10; 59746-115-06; 59746-115-10
Status Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
59746-113Prochlorperazine Maleate Prochlorperazine MaleateTabletOralJubilant Cadista Pharmaceuticals Inc.Human Prescription Drug
59746-115Prochlorperazine Maleate Prochlorperazine MaleateTabletOralJubilant Cadista Pharmaceuticals Inc.Human Prescription Drug