azelaic acid

3 recalls on record

Jul 23

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Glenmark Pharmaceuticals Inc., USA — Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.

CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.

FDAHealth

Sep 17

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Glenmark Pharmaceuticals Inc., USA — Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured f

CGMP Deviations: Market complaints received for gritty texture (grainy)

FDAHealth

Jul 22

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Glenmark Pharmaceuticals Inc., USA — Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa, 403513, India, Manufactured for: Glenm

CGMP Deviations

FDAHealth