Valsartan Tablet
FDA Recall NDC 71335-0567
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Valsartan (NDC 71335-0567). A significant event, classified as Class II, was initiated on Jul 27, 2018 by Bryant Ranch Prepack. The reported reason for this action was: "CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Jul 27, 2018
Aug 08, 2018
90 tablets
Recall Profile & Regulatory Data
Event ID
80634
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Bryant Ranch Prepack Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed in HI, IN, and FL.
Termination Date
Apr 22, 2021
Product Description
Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
Batch or Lot Expiration Information
Lot# 120879; Exp 10/19
Affected Packages Involved in this Recall
71335-0567-1Product
71335-0567-2Product
71335-0567-3Product
71335-0567-4Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
