Recall Enforment Report D-1021-2018
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by RemedyRepack Inc., originally initiated on 07-17-2018 for the product Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701 The product was recalled due to cgmp deviations: carcinogen impurity detected in api used to manufacture drug product.. The product was distributed in Product Was Distributed To 3 Medical Facilities In Florida. 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-1021-2018 | 07-17-2018 | 08-08-2018 | Class II | 3 HDPE 90-count bottles (270 tablets) | Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Terminated |
| D-1020-2018 | 07-17-2018 | 08-08-2018 | Class II | 4 HDPE 90-count bottles (360 tablets) | Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701 | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Terminated |
