Valsartan Tablets recalled over manufacturing violations
- Recall date
- August 14, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- AVKARE Inc. recalls Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, Inc. Pulas…
- Recall number
- D-1132-2018
- FDA classification
- Class II
- Brand / firm
- AVKARE Inc.
- Sold / distributed
- U.S. Nationwide
Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug 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
Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
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