Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Ma...
FDA Recall #D-0145-2020 — Class II — September 4, 2019
Product Description
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
Reason for Recall
CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
Recalling Firm
Jubilant Cadista Pharmaceuticals, Inc. — Salisbury, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
63,216 bottles
Distribution
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.
Code Information
Lot # PA218P008, PA218P009, Exp 04/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated