Valsartan And Hydrochlorothiazide Tablet, Film Coated
FDA Recall NDC 65862-548

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 And Hydrochlorothiazide (NDC 65862-548). A significant event, classified as Class II, was initiated on Dec 31, 2018 by Aurobindo Pharma Limited. The reported reason for this action was: "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."

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

D-0366-2019ONGOINGD-0368-2019ONGOINGD-0365-2019ONGOINGD-0369-2019ONGOINGD-0367-2019ONGOING

December 2018 Class II Recall: CGMP Deviations

Recall Number
D-0366-2019
Class II Ongoing
Reason for Recall
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.
Initiated
Dec 31, 2018
Reported
Jan 23, 2019
Quantity
92,616 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 and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-548-90.
Batch or Lot Expiration Information
Lot# HTSA17033-A, exp. date 10/2020
Lot# HTSA17034-A, exp. date 10/2020
Lot# HTSA17035-A, exp. date 10/2020
Lot# HTSA17036-A, exp. date 10/2020
Lot# HTSA17040-A, exp. date 10/2020
Lot# HTSA17041-A, exp. date 11/2020
Lot# HTSA17042-A, exp. date 11/2020
Lot# HTSA17043-A, exp. date 11/2020
Lot# HTSA17037-A, exp. date 10/2020
Lot# HTSA17039-A, exp. date 10/2020
Affected Packages Involved in this Recall
65862-547-90Product
65862-547-99Product
65862-547-10Product
65862-548-90Product
65862-548-99Product
65862-548-10Product
65862-549-90Product
65862-549-99Product
65862-549-10Product
65862-550-90Product
65862-550-05Product
65862-551-90Product
65862-551-05Product

December 2018 Class II Recall: CGMP Deviations

Recall Number
D-0368-2019
Class II Ongoing
Reason for Recall
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.
Initiated
Dec 31, 2018
Reported
Jan 23, 2019
Quantity
32,160 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 and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-547-90.
Batch or Lot Expiration Information
Lot# HVSA17011-A, exp. date 11/2020
Lot# HVSA17012-A, exp. date 11/2020
Lot# HVSA18001-A, exp. date 12/2020
Affected Packages Involved in this Recall
65862-547-90Product
65862-547-99Product
65862-547-10Product
65862-548-90Product
65862-548-99Product
65862-548-10Product
65862-549-90Product
65862-549-99Product
65862-549-10Product
65862-550-90Product
65862-550-05Product
65862-551-90Product
65862-551-05Product

December 2018 Class II Recall: CGMP Deviations

Recall Number
D-0365-2019
Class II Ongoing
Reason for Recall
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.
Initiated
Dec 31, 2018
Reported
Jan 23, 2019
Quantity
23,016 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 and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-550-90.
Batch or Lot Expiration Information
Lot# HRSA17033-A, exp. date 10/2020
Lot# HRSA17034-A, exp. date 10/2020
Lot# HRSA17035-A, exp. date 10/2020
Lot# HRSA17036-A, exp. date 10/2020
Lot# HRSA17037-A, exp. date 10/2020
Affected Packages Involved in this Recall
65862-547-90Product
65862-547-99Product
65862-547-10Product
65862-548-90Product
65862-548-99Product
65862-548-10Product
65862-549-90Product
65862-549-99Product
65862-549-10Product
65862-550-90Product
65862-550-05Product
65862-551-90Product
65862-551-05Product

December 2018 Class II Recall: CGMP Deviations

Recall Number
D-0369-2019
Class II Ongoing
Reason for Recall
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.
Initiated
Dec 31, 2018
Reported
Jan 23, 2019
Quantity
53,064 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 and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-549-90.
Batch or Lot Expiration Information
Lot# HVSB17023-A, exp. date 08/2020
Lot# HVSB17036-A, exp. date 11/2020
Lot# HVSB17037-A, exp. date 11/2020
Lot# HVSB17038-A, exp. date 11/2020
Lot# HVSB17039-A, exp. date 11/2020
Lot# HVSB17040-B, exp. date 11/2020
Lot# HVSB18001-A, exp. date 12/2020
Lot# HVSB18002-A, exp. date 12/2020
Lot# HVSB18003-A, exp. date 12/2020
Lot# HVSB18004-A, exp. date 12/2020
Affected Packages Involved in this Recall
65862-547-90Product
65862-547-99Product
65862-547-10Product
65862-548-90Product
65862-548-99Product
65862-548-10Product
65862-549-90Product
65862-549-99Product
65862-549-10Product
65862-550-90Product
65862-550-05Product
65862-551-90Product
65862-551-05Product

December 2018 Class II Recall: CGMP Deviations

Recall Number
D-0367-2019
Class II Ongoing
Reason for Recall
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.
Initiated
Dec 31, 2018
Reported
Jan 23, 2019
Quantity
111,239 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 and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-551-90.
Batch or Lot Expiration Information
Lot# HTSB17049-A, exp. date 08/2020
Lot# HTSB17054-A, exp. date 10/2020
Lot# HTSB17055-A, exp. date 10/2020
Lot# HTSB17056-A, exp. date 10/2020
Lot# HTSB17057-A, exp. date 10/2020
Lot# HTSB17058-A, exp. date 10/2020
Lot# HTSB17059-A, exp. date 10/2020
Lot# HTSB17060-A, exp. date 10/2020
Lot# HTSB17062-A, exp. date 10/2020
Lot# HTSB17066-A, exp. date 10/2020
Lot# HTSB17067-A, exp. date 11/2020
Lot# HTSB17068-A, exp. date 11/2020
Lot# HTSB17069-A, exp. date 11/2020
Lot# HTSB18001-A, exp. date 12/2020
Lot# HTSB18002-A, exp. date 12/2020
Lot# HTSB18003-A, exp. date 12/2020
Lot# HTSB18004-A, exp. date 12/2020
Lot# HTSB18005-A, exp. date 12/2020
Lot# HTSB18006-A, exp. date 12/2020
Lot# HTSB18007-A, exp. date 12/2020
Lot# HTSB17063-A, exp. date 10/2020
Lot# HTSB17064-A, exp. date 10/2020
Lot# HTSB17065-A, exp. date 10/2020
Lot# HTSB18029-A, exp. date 03/2021
Affected Packages Involved in this Recall
65862-547-90Product
65862-547-99Product
65862-547-10Product
65862-548-90Product
65862-548-99Product
65862-548-10Product
65862-549-90Product
65862-549-99Product
65862-549-10Product
65862-550-90Product
65862-550-05Product
65862-551-90Product
65862-551-05Product

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.