FDAClass IIMay 8, 2013

Pantoprazole Sodium Delayed Release Tablets USP recall: CGMP Deviations

Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed…

Why was Pantoprazole Sodium Delayed Release Tablets USP recalled?

cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.

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 PA22028 Exp 5/2014 Lot PA22029 Exp 5/2014

Product
Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed…
Recalling firm
Jubilant Cadista Pharmaceuticals Inc.
Quantity
12770 bottles
Distribution
Nationwide
Recall date
May 8, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls