Amlodipine and Valsartan Tablets recalled over manufacturing violations
- Recall date
- November 20, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Mylan Pharmaceuticals Inc. recalls Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Ph…
- Recall number
- D-0311-2019
- FDA classification
- Class II
- Brand / firm
- Mylan Pharmaceuticals Inc.
- Sold / distributed
- Product was distributed throughout the United States.
Why it was recalled
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the 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
Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1721-93.
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