FDAClass IIApril 10, 2019

Pantoprazole Sodium Delayed-Release Tablets recall

Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx Only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India…

Why was Pantoprazole Sodium Delayed-Release Tablets recalled?

Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: PA217060A, Exp 05/2020

Product
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx Only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India…
Recalling firm
Jubilant Cadista Pharmaceuticals, Inc.
Quantity
12,960 bottles
Distribution
Nationwide in the USA.
Recall date
April 10, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls