March 2020 FDA Recall Drug by Jubilant Cadista Pharmaceuticals, Inc.
D-1058-2020 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Jubilant Cadista Pharmaceuticals, Inc. on March 11, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1058-2020

Reason for Recall
CGMP Deviations: Presence of dark brown discoloration on edges of tablets
Initiated
03-11-2020
Reported
03-25-2020
Quantity
89,376 90-count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85181
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Jubilant Cadista Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-10-2020
Product Description About Product Description
Full technical description of the product.
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 India, NDC 59746-284-90

Batch or Lot Expiration Information

Lot# PA218005A, exp. date 12/2020, PA218P010, PA218P011, exp. date 04/2021, PA218108A, PA218110A, exp. date 06/2021