FDA-Drug2020-03-25Class II

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

Jubilant Cadista Pharmaceuticals, Inc.
Hazard

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

Sold states
Distributed Nationwide in the USA
Affected count
89,376 90-count bottles
Manufactured in
207 Kiley Dr, Salisbury, MD, United States
Products
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

Official notice

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

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