Jubilant Cadista Pharmaceuticals, Inc. recalls Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant
Recalled October 23, 2019 · FDA recall D-0145-2020 · Jubilant Cadista Pharmaceuticals
Hazard
CGMP Deviation: Presence of dark brown discoloration on edges of tablets. · FDA Class II
Units
63,216 bottles
Sold at
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.
Description
CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
Product
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
Manufacturer(s)
Jubilant Cadista Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →