Unit Dose Valsartan Tablets recalled over manufacturing violations
- Recall date
- July 18, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- MAJOR PHARMACEUTICALS recalls Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6…
- Recall number
- D-0966-2018
- FDA classification
- Class II
- Brand / firm
- MAJOR PHARMACEUTICALS
- Sold / distributed
- 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
Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.
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