Amlodipine And Valsartan 5 mg / 160 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:3064084, 3069629, 3073148, 3073149,3076093, 3077772
• 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: 3064085, 3066063,3069638,3069639
• 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: 3064086, 3066061, 3066062,3073145,3073146,3073147, 3076091, 3077619, 3082432
• 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: 3066064, 3069645, 3069646, 3073142, 3073143, 3073144, 3077617
• 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 # 3066051, exp. date 3/2019
• 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 # 3079500, exp. date 1/2020
• 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 # 3061986, exp. date 11/2018 Lot # 3079709, exp. date 1/2020 Lot # 3077618, exp. date 11/2019 Lot # 3079708, exp. date 1/2020

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

Product details

Generic drug

Amlodipine and Valsartan: every company that makes it

Form

tablet, film coated, oral

Strength

5 mg / 160 mg

Approval

ANDA ANDA090483

On the market since

Mar 30, 2015

Package NDCs

0378-1721-93

Official label

DailyMed (National Library of Medicine), updated Aug 31, 2021

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