RemedyRepack Inc. recalls Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4,
Recalled August 22, 2018 · FDA recall D-1102-2018 · RemedyRepack
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. · FDA Class II
Units
36 bottles of 90 = 3240 tablets
Sold at
Product was distributed to three customers in FL and VA.
Description
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product
Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0793-19
Manufacturer(s)
RemedyRepack Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →