FDA-Drug2019-10-23Class II
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
Jubilant Cadista Pharmaceuticals, Inc.
Hazard
CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
Sold states
Product was distributed to MS, OH, RI, TN and Puerto Rico to distributors and wholesalers who may have further distributed the product to the retail level.
Affected count
63,216 bottles
Manufactured in
207 Kiley Dr, N/A, Salisbury, MD, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0145-2020Don't want to check this manually?
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