FDA-Drug2018-08-08Class II
Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), 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
690 tablets
Manufactured in
1919 N Victory Pl, N/A, Burbank, CA, United States
Products
Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1027-2018Don't want to check this manually?
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