D-1027-2018 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
- 690 tablets
Product Description
Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), 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 # 111158; Exp. 02/19