D-1028-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 8, 2018
- Initiation Date
- July 27, 2018
- Termination Date
- April 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 990 tablets
Product Description
Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles (NDC 6362-96905-3), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Distribution Pattern
Product was distributed in HI, IN, and FL.
Code Information
Lot # 114319; Exp. 10/18 Lot # 109004; Exp. 12/18