RANITIDINE TABLETS recalled over manufacturing violations
- Recall date
- December 13, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Granules India Limited recalls RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
- Recall number
- D-0632-2020
- FDA classification
- Class II
- Brand / firm
- Granules India Limited
- Sold / distributed
- OR, NY, NJ
Why it was recalled
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
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