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Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Ca...

FDA Recall #D-0098-2025 — Class II — November 1, 2024

Recall #D-0098-2025 Date: November 1, 2024 Classification: Class II Status: Ongoing

Product Description

Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-555-01.

Reason for Recall

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Recalling Firm

Glenmark Pharmaceuticals Inc., USA — Mahwah, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

7296 bottles

Distribution

Nationwide in the USA

Code Information

Lot #:17222547, Exp. Date, 11/30/2024; 17230598, Exp. Date 02/28/2025

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

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