D-1029-2018 Class II Terminated
FDA drug recall D-1029-2018 was initiated by Bryant Ranch Prepack Inc. on July 27, 2018 and is designated Class II. Reason for recall: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. The recall status is terminated (terminated April 22, 2021). Affected quantity: 90 tablets.
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
- 90 tablets
Product Description
Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), 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 # 120879; Exp 10/19