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 4354
Recalled August 8, 2018 · FDA recall D-1022-2018 · H J Harkins Company Inc
Hazard
Carcinogen impurity detected in API used to manufacture drug product. · FDA Class II
Units
540 tablets
Sold at
Product was distributed to a physician's office.
Description
Carcinogen impurity detected in API used to manufacture drug product.
Product
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.
Manufacturer(s)
H J Harkins Company Inc dba Pharma Pac
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →