December 2021 FDA Recall Drug by Torrent Pharma Inc.
D-0285-2022 - Superpotent; Hydrochlorothiazide

This Class III drug recall was voluntarily initiated by Torrent Pharma Inc. on December 1, 2021 for the product Drug. The FDA reported the reason for recall as superpotent; hydrochlorothiazide. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0285-2022

Reason for Recall
Superpotent; Hydrochlorothiazide
Initiated
12-01-2021
Reported
12-22-2021
Quantity
27,312 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89141
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Torrent Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-12-2024
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Batch# Batch: BZ74G001 Exp. 12/2021.