FDAClass IIAugust 7, 2024

Glenmark recall: CGMP Deviations

Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa, 403513, India…

Why was Glenmark recalled?

CGMP Deviations

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot# 19241453; Exp MARCH 2026

Product
Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa, 403513, India…
Recalling firm
Glenmark Pharmaceuticals Inc., USA
Quantity
14,004 cartons
Distribution
U.S. Nationwide
Recall date
August 7, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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