1. Home
  2. Drug Recall Enforcement Reports
  3. Recall Enforcement Event ID: 80557

Recall Enforment Report D-0966-2018

Recall Details

Multi event Drug Recall Enforcement Report Class II done by MAJOR PHARMACEUTICALS, originally initiated on 07-18-2018 for the product Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. The product was recalled due to cgmp deviations: carcinogen impurity detected in api used to manufacture drug product.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0966-201807-18-201808-01-2018Class II5,464 cartonsUnit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.Terminated
D-0967-201807-18-201808-01-2018Class II4,556 cartonsUnit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. NDC# 0904-6595-61.CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.Terminated