FDA-Drug2024-08-07Class II

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.

Glenmark Pharmaceuticals Inc., USA
Hazard

CGMP Deviations

Sold states
U.S. Nationwide
Affected count
14,004 cartons
Manufactured in
750 Corporate Dr, N/A, Mahwah, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0621-2024

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