The Recall Desk
SevereFDA (Drugs)·D-0312-2019·Announced 2018-12-19

Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

Mylan Pharmaceuticals is recalling Amlodipine and Valsartan tablets because FDA testing confirmed the presence 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 severity score under the rubric, particularly given the presence of a known carcinogenic impurity (NDEA) in a prescription drug.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling Amlodipine and Valsartan Tablets, USP, 10 mg/160 mg, 30-count bottles. The recall involves 12,336 bottles of the prescription medication, which was distributed throughout the United States. The specific lot affected is #3079500 with an expiration date of 1/2020.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of N-nitrosodiethylamine (NDEA), an impurity contained in the active pharmaceutical ingredient (API) used to manufacture the product.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider for guidance on alternative treatments. The product is identified by NDC 0378-1722-93.

The recalled product

Product
AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
Brand
AMLODIPINE AND VALSARTAN
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
12,336

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 (2)

  • Lot # 3079500
  • exp. date 1/2020

UPCs (4)

  • 0303781722933
  • 0303781723930
  • 0303781721936
  • 0303781724937

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 8 recalled by Mylan Pharmaceuticals Inc. 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 8 products in this recall →

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Same hazard · impurity

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