Ranitidine Tablets recalled over manufacturing violations
- Recall date
- December 20, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Denton Pharma, Inc. recalls Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Onl…
- Recall number
- D-0795-2020
- FDA classification
- Class II
- Brand / firm
- Denton Pharma, Inc.
- Sold / distributed
- Nationwide
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
Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131
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