The Recall Desk
SevereFDA (Drugs)·D-0331-2019·Announced 2018-12-19

Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

Mylan is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA).

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 recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric for significant potential health risks associated with drug impurities.

Plain-English summary

Mylan Laboratories Limited is recalling 19,352 bottles of Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg. The affected products are available in 90-count and 500-count bottles and were distributed throughout the United States, including Puerto Rico.

The recall was initiated because FDA analysis confirmed the presence of trace amounts of N-nitrosodiethylamine (NDEA), an impurity found in the active pharmaceutical ingredient (API) used to manufacture the product. The specific lot numbers involved are 3084889, 3084890, and 3093803.

Consumers and healthcare providers should check their medication bottles for these specific lot numbers and NDC codes (0378-6324-77 or 0378-6324-05). If the medication matches the recalled description, patients should stop taking it and contact their healthcare provider or pharmacist for guidance on alternative treatment options.

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
19,352

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 (1)

  • Lot numbers: 3084889 3084890 3093803

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 · impurity

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