FDA-Drug2018-10-17Class II

Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 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.

Jubilant Cadista Pharmaceuticals, Inc.
Hazard

Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.

Sold states
Product was distributed Nationwide in the USA and Puerto Rico.
Affected count
158,466 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; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0011-2019

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