FDA-Drug2018-08-08Class II
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.
Bryant Ranch Prepack Inc.
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Sold states
Product was distributed in HI, IN, and FL.
Affected count
990 tablets
Manufactured in
1919 N Victory Pl, N/A, Burbank, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1028-2018Don't want to check this manually?
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