Recall: D-0852-2022

Class II - Potentially Harmful

Class IIClassification

2022-04-11Initiated

TerminatedStatus

Torrent Pharma IncFirm

Product

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

CGMP deviations: tablets cracking

Distribution

Nationwide in the U.S.A

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.