The Recall Desk
SevereFDA (Drugs)·D-0328-2019·Announced 2018-12-19

Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

Mylan is recalling Valsartan and Hydrochlorothiazide 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 known carcinogenic impurity, 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 specific lots of Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg. The recall involves 32,696 HDPE bottles in 90-count and 500-count sizes. The product was distributed throughout the United States, including Puerto Rico, to several major distributors.

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. The affected lot numbers are 3084363, 3084364, 3093800, 3084363, and 3093800.

Consumers and healthcare providers should check their medication bottles for the affected lot numbers and NDC codes (0378-6321-77, 0378-6321-05, and associated NDCs). If the medication matches the recalled lots, patients should contact their healthcare provider for guidance on alternative treatment options and stop using the product as directed by their provider.

The recalled product

Product
VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
Brand
VALSARTAN AND HYDROCHLOROTHIAZIDE
Manufacturer
Mylan Laboratories Limited, (Nashik FDF)
Category
Drug — Prescription Medication
Hazard
Affected units
32,696

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 (4)

  • Lot numbers: 3084363
  • 3084364
  • 3093800
  • 3084363

UPCs (1)

  • 0303786323777

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 · VALSARTAN AND HYDROCHLOROTHIAZIDE

Same manufacturer · Mylan Laboratories Limited, (Nashik FDF)

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Same hazard · nde contamination

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