Recall Enforment Report D-1108-2018
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by A-S Medication Solutions LLC., originally initiated on 07-17-2018 for the product Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC 54569-6583-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China 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 ongoing.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-1108-2018 | 07-17-2018 | 08-29-2018 | Class II | 666 bottles | Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC 54569-6583-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Ongoing |
| D-1109-2018 | 07-17-2018 | 08-29-2018 | Class II | 178 bottles | Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle (NDC 54569-6582-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Ongoing |
| D-1111-2018 | 07-17-2018 | 08-29-2018 | Class II | 531 bottles | Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiazide 25 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6488-0 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Ongoing |
| D-1110-2018 | 07-17-2018 | 08-29-2018 | Class II | 524 bottles | Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6480-0 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Ongoing |
