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FDAFDA · Food and drugs·Recall number D-0011-2019

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.

Published October 17, 2018 · Recall initiated: October 2, 2018

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Jubilant Cadista Pharmaceuticals, Inc.
Distributor
Product was distributed Nationwide in the USA and Puerto Rico.
Lot
Lot #: PA26038A, Exp 04/19; PA26039A, PA26040A, PA26050A, Exp 05/19; PA26052A, Exp 06/19; PA26073A, Exp 07/19; PA217071A, PA217072A, PA217073B, PA217074B, Exp 06/20; PA217101A, Exp 08/20; and PA218023A, Exp 01/21.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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