Drug product
Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0791-19
D-1100-2018
Product summary
- Event
- Event 80827
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 bottles of 90 = 810 tablets
- Official record key
drug-enforcement:D-1100-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Lot # B0335344-081717, exp. date 08/2018 Lot # B0363364-110917, exp. date 11/2018 Lot # B0391225-012218, exp. date 01/2019 Lot # B0408458-030618, exp. date 03/2019 Lot # B0384871-010318, exp. date 01/2019 Lot # B0436862-051518, exp. date 05/2019
Distribution pattern: Product was distributed to three customers in FL and VA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations