D-0852-2022 Class II Terminated

Recalled by Torrent Pharma Inc — Levittown, PA

Recall Details

Product Type
Drugs
Report Date
May 11, 2022
Initiation Date
April 11, 2022
Termination Date
July 25, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24,888 bottles

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

Distribution Pattern

Nationwide in the U.S.A

Code Information

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