FDAClass IIMay 11, 2022

Pantoprazole Sodium Delayed-Release Tablets recall: CGMP Deviations

Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382…

Why was Pantoprazole Sodium Delayed-Release Tablets recalled?

CGMP deviations: tablets cracking

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 #s: BA34G021, BA34G022, Exp. 09/2022

Product
Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382…
Recalling firm
Torrent Pharma Inc
Quantity
24,888 bottles
Distribution
Nationwide in the U.S.A
Recall date
May 11, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls