Pantoprazole Sodium Delayed Release Tablets recalled over manufacturing violations

Recall date

September 4, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Jubilant Cadista Pharmaceuticals, Inc. recalls Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilan…

Recall number

D-0145-2020

FDA classification

Class II

Brand / firm

Jubilant Cadista Pharmaceuticals, Inc.

Sold / distributed

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.

Why it was recalled

CGMP Deviation: Presence of dark brown discoloration on edges of tablets.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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