PlainRecalls
FDA Drug Moderate Class II Terminated

Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382 721, India, Manufactured for: Torrent Pharma Inc., Levittown, PA 19057, NDC# 13668-096-90.

Reported: May 11, 2022 Initiated: April 11, 2022 #D-0852-2022

Product Description

Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382 721, India, Manufactured for: Torrent Pharma Inc., Levittown, PA 19057, NDC# 13668-096-90.

Reason for Recall

CGMP deviations: tablets cracking

Details

Recalling Firm
Torrent Pharma Inc
Units Affected
24,888 bottles
Distribution
Nationwide in the U.S.A
Location
Levittown, PA

Frequently Asked Questions

What product was recalled?
Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382 721, India, Manufactured for: Torrent Pharma Inc., Levittown, PA 19057, NDC# 13668-096-90.. Recalled by Torrent Pharma Inc. Units affected: 24,888 bottles.
Why was this product recalled?
CGMP deviations: tablets cracking
Which agency issued this recall?
This recall was issued by the FDA Drug on May 11, 2022. Severity: Moderate. Recall number: D-0852-2022.