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