H J Harkins Company Inc dba Pharma Pac recalls Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC 435…

Recall date

July 26, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1022-2018

FDA classification

Class II

Brand / firm

H J Harkins Company Inc dba Pharma Pac

Sold / distributed

Product was distributed to a physician's office.

Why it was recalled

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 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.