Torrent Pharma Inc: Drug Recall

Recall #D-0852-2022 · 04/11/2022

Class II: Risk

Recall Details

Recall Number: D-0852-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Torrent Pharma Inc
Status: Terminated
Date Initiated: 04/11/2022
Location: Levittown, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 24,888 bottles

Reason for Recall

CGMP deviations: tablets cracking

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.

Distribution Pattern

Nationwide in the U.S.A

Other Recalls by Torrent Pharma Inc

Class II: Risk 05/27/2025

CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Class II: Risk 05/27/2025

CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Class II: Risk 12/02/2021

Failed Dissolution Specifications
Class III: Low Risk 12/01/2021

Superpotent; Hydrochlorothiazide

View all recalls by Torrent Pharma Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.