Ranitidine Tablets recalled over manufacturing violations
- Recall date
- November 22, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Amneal Pharmaceuticals, Inc. recalls Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c)…
- Recall number
- D-0613-2020
- FDA classification
- Class II
- Brand / firm
- Amneal Pharmaceuticals, Inc.
- Sold / distributed
- Product was distributed throughout the United States.
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 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).
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