Cinacalcet Tablets recalled over manufacturing violations
- Recall date
- October 9, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Dr. Reddy's Laboratories, Inc. recalls Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India,…
- Recall number
- D-0026-2025
- FDA classification
- Class II
- Brand / firm
- Dr. Reddy's Laboratories, Inc.
- Sold / distributed
- USA Nationwide.
Why it was recalled
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.
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