Ranitidine Tablets recalled over manufacturing violations
- Recall date
- December 2, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Preferred Pharmaceuticals, Inc recalls Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06),…
- Recall number
- D-0617-2020
- FDA classification
- Class II
- Brand / firm
- Preferred Pharmaceuticals, Inc
- Sold / distributed
- CA, FL
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 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals
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