Valsartan and Hydrochlorothiazide 320 mg / 12.5 mg tablet, film coated

Where it's made

This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Mylan Pharmaceuticals Inc. names for other drugs.

Recalls

• Dec 4, 2018 · Class II · Mylan Laboratories Limited, (Nashik FDF)
  GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
  Lots: Lot numbers: 3084363, 3084364, 3093800, 3084363, 3093800
• Dec 4, 2018 · Class II · Mylan Laboratories Limited, (Nashik FDF)
  GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
  Lots: Lot numbers: 2008880 3084358 3084359 3093801 3084359 3084361 3093801
• Dec 4, 2018 · Class II · Mylan Laboratories Limited, (Nashik FDF)
  GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
  Lots: Lot numbers: 3084887 3093802 3084887 3084888 3093802
• Dec 4, 2018 · Class II · Mylan Laboratories Limited, (Nashik FDF)
  GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
  Lots: Lot numbers: 3084889 3084890 3093803
• Dec 4, 2018 · Class II · Mylan Laboratories Limited, (Nashik FDF)
  GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
  Lots: Lot numbers: 3084860 3084861 3084862 3093804 3084862 3084863
• Nov 20, 2018 · Class II · Mylan Pharmaceuticals Inc.
  CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
  Lots: Lot # 3084886, exp. date 2/2019 Lot # 3093804, exp. date 12/2019

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Product details

Generic drug

Hydrochlorothiazide and Valsartan: every company that makes it

Form

tablet, film coated, oral

Strength

320 mg / 12.5 mg

Approval

ANDA ANDA078020

On the market since

Sep 21, 2012

Package NDCs

0378-6324-05 0378-6324-77

Official label

DailyMed (National Library of Medicine), updated Apr 27, 2023

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