FDA-Drug2018-08-22Class II
Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC: 61786-0792-19
RemedyRepack Inc.
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Sold states
Product was distributed to three customers in FL and VA.
Affected count
21 bottles of 90 = 1890 tablets
Manufactured in
625 Kolter Dr Ste 4, Indiana, PA, United States
Products
Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC: 61786-0792-19
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1101-2018Don't want to check this manually?
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