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

Recall Number: D-0145-2020

Firm: Jubilant Cadista Pharmaceuticals, Inc.

Classification: Class II

Status: Terminated

Report Date: 20191023

Initiation Date: 20190904

Termination Date: 20200212

Reason for Recall

CGMP Deviation: Presence of dark brown discoloration on edges of tablets.

Product Description

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