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.
Carcinogen impurity detected in API used to manufacture drug product.
Product was distributed to a physician's office.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1022-2018