The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0315-2019·Announced 2018-12-19

Mylan Recalls Valsartan Tablets Due to NDEA Impurity

Mylan Pharmaceuticals is recalling Valsartan 40 mg tablets because FDA labs confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).

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 severity score under the rubric for significant injury or health risk reports.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling 63,213 bottles of Valsartan Tablets, USP, 40 mg. The product is a prescription-only medication manufactured in India for Mylan Pharmaceuticals, Inc., located in Morgantown, WV. The specific lot number is 3061169, with an expiration date of 11/2018.

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

The product was distributed throughout the United States. Patients and healthcare providers should stop using the affected lot and contact their healthcare provider for alternative treatment options. Consumers should not return the medication to the pharmacy unless instructed to do so by the manufacturer or FDA.

The recalled product

Product
VALSARTAN (VALSARTAN)
Brand
VALSARTAN
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
63,213

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 # 3061169
  • exp. date 11/2018

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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