FDA recall D-0852-2022

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 for recall

CGMP deviations: tablets cracking

Distribution

Nationwide in the U.S.A

Key facts

Status

Terminated

Initiation date

2022-04-11

Report date

2022-05-11

Termination date

2023-07-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Levittown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0852-2022