Valsartan 320 mg tablets recalled over manufacturing violations
- Recall date
- July 27, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Bryant Ranch Prepack Inc. recalls Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles (…
- Recall number
- D-1028-2018
- FDA classification
- Class II
- Brand / firm
- Bryant Ranch Prepack Inc.
- Sold / distributed
- Product was distributed in HI, IN, and FL.
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 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles (NDC 6362-96905-3), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
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