Mylan Laboratories Limited, (Nashik FDF) recalls Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharm…
- Recall date
- December 4, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0320-2019
- FDA classification
- Class II
- Brand / firm
- Mylan Laboratories Limited, (Nashik FDF)
- Sold / distributed
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
Why it was recalled
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found 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 5/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-1721-93.
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