D-1102-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 22, 2018
- Initiation Date
- August 10, 2018
- Termination Date
- October 12, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36 bottles of 90 = 3240 tablets
Product Description
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
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Distribution Pattern
Product was distributed to three customers in FL and VA.
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