FDA recall D-1058-2020

Jubilant Cadista Pharmaceuticals, Inc. · Class II · drug

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

Reason for recall

CGMP Deviations: Presence of dark brown discoloration on edges of tablets

Distribution

Distributed Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2020-03-11
Report date: 2020-03-25
Termination date: 2020-06-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Salisbury, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1058-2020