Recall Enforment Report D-0011-2019

Drug Recall Enforcement Report Class II voluntary initiated by Jubilant Cadista Pharmaceuticals, Inc., originally initiated on 10-02-2018 for the product Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90. The product was recalled due to discoloration: presence of dark discoloration or brown spots on the edges of the tablets.. The product was distributed nationwide and the recall is currently terminated.

Field Name	Field Value
Event ID	81162 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0011-2019 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote 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 Nationwide in the USA and Puerto Rico. 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	Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90.
Reason For Recall	Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	158,466 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	10-17-2018
Recall Initiation Date	10-02-2018 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	02-24-2020 What is the Date Terminated? The date that FDA terminated 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 #: PA26038A, Exp 04/19; PA26039A, PA26040A, PA26050A, Exp 05/19; PA26052A, Exp 06/19; PA26073A, Exp 07/19; PA217071A, PA217072A, PA217073B, PA217074B, Exp 06/20; PA217101A, Exp 08/20; and PA218023A, Exp 01/21. 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	59746-283-30; 59746-283-90; 59746-283-01; 59746-283-05; 59746-283-10; 59746-283-03; 59746-284-30; 59746-284-90; 59746-284-01; 59746-284-05; 59746-284-10; 59746-284-03
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