Glenmark Pharmaceuticals Inc. product recalled over manufacturing violations
- Recall date
- December 17, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Glenmark Pharmaceuticals Inc., USA recalls Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bande…
- Recall number
- D-0643-2020
- FDA classification
- Class II
- Brand / firm
- Glenmark Pharmaceuticals Inc., USA
- Sold / distributed
- Natiowide
Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
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 Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-20
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