FDA-Drug2018-08-08Class II
Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC 43547-0369-09. Tablet is yellow, capsule-shaped, biconvex, film-coated tablets debossed with 343 on one side and HH on the other side.
Hazard
Carcinogen impurity detected in API used to manufacture drug product.
Sold states
Product was distributed to a physician's office.
Affected count
540 tablets
Manufactured in
1400 W Grand Ave Ste F, N/A, Grover Beach, CA, United States
Products
Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC 43547-0369-09. Tablet is yellow, capsule-shaped, biconvex, film-coated tablets debossed with 343 on one side and HH on the other side.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1022-2018Don't want to check this manually?
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