Torrent Pharma Inc.: Drug Recall

Recall #D-0285-2022 · 12/01/2021

Class III: Low Risk

Recall Details

Recall Number: D-0285-2022
Classification: Class III
Product Type: Drug
Recalling Firm: Torrent Pharma Inc.
Status: Terminated
Date Initiated: 12/01/2021
Location: Basking Ridge, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 27,312 Bottles

Reason for Recall

Superpotent; Hydrochlorothiazide

Product Description

Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-159-30

Distribution Pattern

Nationwide USA

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 04/11/2022

CGMP deviations: tablets cracking
Class II: Risk 12/02/2021

Failed Dissolution Specifications

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.