Ranitidine Syrup Oral Solution 15 mg/mL 6 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 Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
- Recall number
- D-0614-2020
- 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 Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
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