Valsartan And Hydrochlorothiazide Tablet, Film Coated
FDA Recall NDC 0378-6321
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 6 recorded enforcement report(s) associated with Valsartan And Hydrochlorothiazide (NDC 0378-6321). A significant event, classified as Class II, was initiated on Dec 04, 2018 by Mylan Pharmaceuticals Inc.. 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 04, 2018
Dec 19, 2018
32,284 HDPE bottles
Recall Profile & Regulatory Data
Event ID
81707
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Mylan Laboratories Limited, (Nashik FDF)
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States to several major distributors, including Puerto Rico.
Product Description
Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles (NDC 0378-6325-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
Batch or Lot Expiration Information
Lot# Lot numbers: 3084860 3084861 3084862 3093804 3084862 3084863
Affected Packages Involved in this Recall
0378-6321-77Product
0378-6321-05Product
0378-6322-77Product
0378-6322-05Product
0378-6323-77Product
0378-6323-05Product
0378-6324-77Product
0378-6324-05Product
0378-6325-77Product
0378-6325-05Product
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 04, 2018
Dec 19, 2018
32,696 HDPE bottles
Recall Profile & Regulatory Data
Event ID
81707
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Mylan Laboratories Limited, (Nashik FDF)
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States to several major distributors, including Puerto Rico.
Product Description
Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count bottles (NDC 0378-6321-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
Batch or Lot Expiration Information
Lot# Lot numbers: 3084363, 3084364, 3093800, 3084363, 3093800
Affected Packages Involved in this Recall
0378-6321-77Product
0378-6321-05Product
0378-6322-77Product
0378-6322-05Product
0378-6323-77Product
0378-6323-05Product
0378-6324-77Product
0378-6324-05Product
0378-6325-77Product
0378-6325-05Product
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 04, 2018
Dec 19, 2018
22,813 HDPE bottles
Recall Profile & Regulatory Data
Event ID
81707
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Mylan Laboratories Limited, (Nashik FDF)
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States to several major distributors, including Puerto Rico.
Product Description
Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (b) 500-count bottles (NDC 0378-6323-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
Batch or Lot Expiration Information
Lot# Lot numbers: 3084887 3093802 3084887 3084888 3093802
Affected Packages Involved in this Recall
0378-6321-77Product
0378-6321-05Product
0378-6322-77Product
0378-6322-05Product
0378-6323-77Product
0378-6323-05Product
0378-6324-77Product
0378-6324-05Product
0378-6325-77Product
0378-6325-05Product
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 04, 2018
Dec 19, 2018
50,595 HDPE bottles
Recall Profile & Regulatory Data
Event ID
81707
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Mylan Laboratories Limited, (Nashik FDF)
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States to several major distributors, including Puerto Rico.
Product Description
Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-count bottles (NDC 0378-6322-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
Batch or Lot Expiration Information
Lot# Lot numbers: 2008880 3084358 3084359 3093801 3084359 3084361 3093801
Affected Packages Involved in this Recall
0378-6321-77Product
0378-6321-05Product
0378-6322-77Product
0378-6322-05Product
0378-6323-77Product
0378-6323-05Product
0378-6324-77Product
0378-6324-05Product
0378-6325-77Product
0378-6325-05Product
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 04, 2018
Dec 19, 2018
19,352 HDPE bottles
Recall Profile & Regulatory Data
Event ID
81707
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Mylan Laboratories Limited, (Nashik FDF)
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States to several major distributors, including Puerto Rico.
Product Description
Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-count bottles (NDC 0378-6324-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
Batch or Lot Expiration Information
Lot# Lot numbers: 3084889 3084890 3093803
Affected Packages Involved in this Recall
0378-6321-77Product
0378-6321-05Product
0378-6322-77Product
0378-6322-05Product
0378-6323-77Product
0378-6323-05Product
0378-6324-77Product
0378-6324-05Product
0378-6325-77Product
0378-6325-05Product
Class II Ongoing
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Nov 20, 2018
Dec 19, 2018
5,660 bottles
Recall Profile & Regulatory Data
Event ID
81613
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Mylan Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States.
Product Description
Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A. NDC 0378-6325-05.
Batch or Lot Expiration Information
Lot# 3084886, exp. date 2/2019
Lot# 3093804, exp. date 12/2019
Affected Packages Involved in this Recall
0378-6321-77Product
0378-6321-05Product
0378-6322-77Product
0378-6322-05Product
0378-6323-77Product
0378-6323-05Product
0378-6324-77Product
0378-6324-05Product
0378-6325-77Product
0378-6325-05Product
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.
