Drug 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
D-1102-2018
Product summary
- Event
- Event 80827
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36 bottles of 90 = 3240 tablets
- Official record key
drug-enforcement:D-1102-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Lot # B0362988-110917, exp. date 10/2018 Lot # B0432265-050318, exp. date 05/2019 Lot # B0450321-061218, exp. date 06/2019 Lot # B0450322-061218, exp. date 05/2019 Lot # B0408652-030718, exp. date 02/2019
Distribution pattern: Product was distributed to three customers in FL and VA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations