Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx Only, Manufactured ...
FDA Recall #D-1074-2019 — Class II — March 29, 2019
Product Description
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.
Reason for Recall
Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the 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
12,960 bottles
Distribution
Nationwide in the USA.
Code Information
Lot #: PA217060A, Exp 05/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated