D-0621-2024Class II

Glenmark Pharmaceuticals Inc., USA

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2024-08-07

Distribution

U.S. Nationwide

Firm state

Product quantity

14,004 cartons

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Risk Management & CAPA

Reason for recall

CGMP Deviations

Product description

Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa, 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52.

Code / lot info

Lot# 19241453; Exp MARCH 2026

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.