Ranitidine Tablets recalled over manufacturing violations
- Recall date
- October 1, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Dr. Reddy's Laboratories, Inc. recalls Ranitidine Tablets, USP 150 mg, NDC 57896-717 (GeriCare) OTC
- Recall number
- D-0185-2020
- FDA classification
- Class II
- Brand / firm
- Dr. Reddy's Laboratories, Inc.
- Sold / distributed
- Product was distributed to major distributors throughout the United States who may have further distributed the product.
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, NDC 57896-717 (GeriCare) OTC
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