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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