Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuti… recall

Why it was recalled

CGMP Deviations

Details

Product

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.

Recalling company

Glenmark Pharms

Classification

Class II

Status

Ongoing

Type

Voluntary: Firm initiated

Distribution

U.S. Nationwide

Initiated

Jul 22, 2024

FDA report date

Aug 7, 2024