Valsartan Tablet, Film Coated
FDA Recall NDC 65862-573
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Valsartan (NDC 65862-573). A significant event, classified as Class II, was initiated on Dec 31, 2018 by Aurobindo Pharma Limited. The reported reason for this action was: "GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Dec 31, 2018
Mar 27, 2019
N/A
Recall Profile & Regulatory Data
Event ID
82114
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to major distribution chains throughout the United States.
Product Description
Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-571-90
Batch or Lot Expiration Information
Lot# Lot Numbers: 471170015A, exp. date Sep 2019; 471180004A, 471180005A, exp. date Feb 2019
Affected Packages Involved in this Recall
65862-570-30Product
65862-570-99Product
65862-570-10Product
65862-571-90Product
65862-571-99Product
65862-571-10Product
65862-572-90Product
65862-572-99Product
65862-572-10Product
65862-573-90Product
65862-573-05Product
Class II Ongoing
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Dec 31, 2018
Mar 27, 2019
N/A
Recall Profile & Regulatory Data
Event ID
82114
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to major distribution chains throughout the United States.
Product Description
Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-570-30
Batch or Lot Expiration Information
Lot# Lot Numbers: 470180008A, exp. date Feb 2020; 470180014A, 470180016A, exp. date Mar 2020; 470180032A, exp. date May 2020
Affected Packages Involved in this Recall
65862-570-30Product
65862-570-99Product
65862-570-10Product
65862-571-90Product
65862-571-99Product
65862-571-10Product
65862-572-90Product
65862-572-99Product
65862-572-10Product
65862-573-90Product
65862-573-05Product
Class II Ongoing
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Dec 31, 2018
Mar 27, 2019
N/A
Recall Profile & Regulatory Data
Event ID
82114
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to major distribution chains throughout the United States.
Product Description
Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-573-90
Batch or Lot Expiration Information
Lot# Lot Numbers: 473180004A, 473180005A, exp. date Feb 2020; 473180006A, exp. date Mar 2020; 473180016A, 473180017A, exp. date May 2020; 473170019A, exp. date Oct 2019
Affected Packages Involved in this Recall
65862-570-30Product
65862-570-99Product
65862-570-10Product
65862-571-90Product
65862-571-99Product
65862-571-10Product
65862-572-90Product
65862-572-99Product
65862-572-10Product
65862-573-90Product
65862-573-05Product
Class II Ongoing
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Dec 31, 2018
Mar 27, 2019
N/A
Recall Profile & Regulatory Data
Event ID
82114
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to major distribution chains throughout the United States.
Product Description
Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90
Batch or Lot Expiration Information
Lot# Lot Numbers: 472180001A, 472180002A, 472180003A, 472180004A, exp. date Jan 2020; 472180007A, 472180008A, 472180009A, 472180010A, exp. date Mar 2020; 472180013A, 472180014A, exp. date Apr 2020
Affected Packages Involved in this Recall
65862-570-30Product
65862-570-99Product
65862-570-10Product
65862-571-90Product
65862-571-99Product
65862-571-10Product
65862-572-90Product
65862-572-99Product
65862-572-10Product
65862-573-90Product
65862-573-05Product
Class II Ongoing
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Dec 31, 2018
Jan 23, 2019
20,604 bottles
Recall Profile & Regulatory Data
Event ID
81887
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
Product Description
Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-573-90.
Batch or Lot Expiration Information
Lot# VUSD17008-A, exp. date 07/2019
Lot# VUSD17009-A, exp. date 09/2019
Affected Packages Involved in this Recall
65862-570-30Product
65862-570-99Product
65862-570-10Product
65862-571-90Product
65862-571-99Product
65862-571-10Product
65862-572-90Product
65862-572-99Product
65862-572-10Product
65862-573-90Product
65862-573-05Product
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.
