September 2019 FDA Recall Drug by Jubilant Cadista Pharmaceuticals, Inc.
D-0145-2020 - CGMP Deviation

This Class II drug recall was voluntarily initiated by Jubilant Cadista Pharmaceuticals, Inc. on September 4, 2019 for the product Drug. The FDA reported the reason for recall as cgmp deviation. The product was distributed in Product was distributed to MS, OH, RI, TN and Puerto Rico to distributors and wholesalers who may have further distributed the product to the retail level. and the recall is currently terminated.

Recall Number: D-0145-2020

Reason for Recall
CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
Initiated
09-04-2019
Reported
10-23-2019
Quantity
63,216 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83705
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.
Product was distributed to MS, OH, RI, TN and Puerto Rico to distributors and wholesalers who may have further distributed the product to the retail level.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-12-2020
Product Description About Product Description
Full technical description of the product.
Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 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

Batch or Lot Expiration Information

Lot# PA218P008, PA218P009, Exp 04/2021