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Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles, Rx only, Manu...

FDA Recall #D-0285-2022 — Class III — December 1, 2021

Recall #D-0285-2022 Date: December 1, 2021 Classification: Class III Status: Terminated

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

Reason for Recall

Superpotent; Hydrochlorothiazide

Recalling Firm

Torrent Pharma Inc. — Basking Ridge, NJ

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

27,312 Bottles

Distribution

Nationwide USA

Code Information

Batch: BZ74G001 Exp. 12/2021.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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