The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0314-2019·Announced 2018-12-19

Mylan Recalls Valsartan Tablets Due to NDEA Impurity

Mylan Pharmaceuticals is recalling Valsartan tablets because FDA labs confirmed the presence of 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. The presence of NDEA, a potential carcinogen, in a prescription drug represents a significant health risk, justifying the higher severity score.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling Valsartan Tablets, USP, 160 mg, 90-count bottles (NDC 0378-5814-77). The recall involves 12,840 bottles of the prescription medication, which was distributed throughout the United States. The specific lot affected is # 3071352 with an expiration date of 7/2019.

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.

Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or distributor for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if they have been taking the affected medication.

The recalled product

Product
VALSARTAN (VALSARTAN)
Brand
VALSARTAN
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
12,840

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 # 3071352
  • exp. date 7/2019

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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