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.
H J Harkins Company Inc dba Pharma Pac
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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