The Recall Desk
SevereFDA (Drugs)·D-0320-2019·Announced 2018-12-19

Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

Mylan is recalling Amlodipine and Valsartan tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA) in the active pharmaceutical ingredient.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the presence of NDEA, a potential carcinogen, in a prescription drug constitutes a significant health risk warranting a Severe rating under the rubric for significant injury/property-damage reports or high-risk contamination.

Plain-English summary

Mylan Laboratories Limited is recalling Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles. The product is a prescription-only medication manufactured in India for Mylan Pharmaceuticals, Inc. The recall involves 141,995 HDPE bottles with specific lot numbers: 3064084, 3069629, 3073148, 3073149, 3076093, and 3077772.

The recall was initiated because FDA analysis confirmed the presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA), in the active pharmaceutical ingredient (API) used to manufacture the product. NDEA is a potential carcinogen.

The affected product was distributed throughout the United States to several major distributors, including Puerto Rico. Consumers and healthcare providers should check their inventory for the listed lot numbers and stop using the product if it matches the recall description. They should contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
Brand
AMLODIPINE AND VALSARTAN
Manufacturer
Mylan Laboratories Limited, (Nashik FDF)
Category
Drug — Prescription Medication
Hazard
Affected units
141,995

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Lot Numbers:3064084
  • 3069629
  • 3073148
  • 3073149
  • 3076093
  • 3077772

UPCs (4)

  • 0303781722933
  • 0303781723930
  • 0303781721936
  • 0303781724937

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 13 recalled by Mylan Laboratories Limited, (Nashik FDF) under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

Related recalls

Same brand · AMLODIPINE AND VALSARTAN

Same manufacturer · Mylan Laboratories Limited, (Nashik FDF)

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Same hazard · nde contamination

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