Drug & medication recalls Moderate risk

Glenmark recalled over manufacturing violations

Recall date
July 22, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Glenmark Pharmaceuticals Inc., USA recalls Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez,…
Recall number
D-0621-2024
FDA classification
Class II
Brand / firm
Glenmark Pharmaceuticals Inc., USA
Sold / distributed
U.S. Nationwide

Why it was recalled

CGMP Deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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