The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0313-2019·Announced 2018-12-19

Mylan Recalls Valsartan Tablets Due to NDEA Impurity

Mylan Pharmaceuticals is recalling Valsartan tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA). The affected product was distributed throughout the United States.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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, particularly given the presence of a known carcinogenic impurity (NDEA) in a prescription drug.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling Valsartan Tablets, USP, 80 mg, 90-count bottles. The specific lot involved is # 3063782 with an expiration date of 1/2019. The product is a prescription-only medication manufactured in India for Mylan Pharmaceuticals, Inc., located in Morgantown, WV.

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

A total of 24,709 bottles were distributed throughout the United States. Consumers and healthcare providers should check their medication for the specific lot number and expiration date listed above. If the medication matches the recalled lot, patients should stop taking it and contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
VALSARTAN (VALSARTAN)
Brand
VALSARTAN
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
24,709

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 # 3063782
  • exp. date 1/2019

UPCs (4)

  • 0303785815778
  • 0303785813774
  • 0303785807933
  • 0303785814771

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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