The Recall Desk
SevereFDA (Drugs)·D-0363-2019·Announced 2019-01-23

Aurobindo Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

Aurobindo Pharma USA Inc. is recalling Amlodipine and Valsartan tablets because FDA labs found N-nitrosodimethylamine (NDEA) above acceptable levels.

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 agency classification is FDA Class II, and the presence of NDEA, a potential carcinogen, above acceptable levels constitutes a significant health risk warranting a Severe rating.

Plain-English summary

Aurobindo Pharma USA Inc. is recalling Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles. The recall involves 27,688 bottles with lot numbers VMSA17012-A through VMSA17017-A, all with an expiration date of 11/2019. The product was distributed to 25 distributors and retail chains who may have further distributed the product throughout the United States.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratories confirmed the presence of the impurity N-nitrosodimethylamine (NDEA) in the active pharmaceutical ingredient (API) used to manufacture the product. The levels of NDEA were found to be above the interim acceptable daily intake level of 0.083 parts per million.

Consumers who have this medication should stop using it and contact their healthcare provider for guidance on alternative treatments. The product is prescription-only, so patients should consult their prescriber before discontinuing or switching medications.

The recalled product

Product
AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
Brand
AMLODIPINE AND VALSARTAN
Manufacturer
Aurobindo Pharma USA Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
27,688

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 (7)

  • Lot # VMSA17012-A
  • exp. date 11/2019 Lot # VMSA17013-A
  • exp. date 11/2019 Lot # VMSA17014-A
  • exp. date 11/2019 Lot # VMSA17015-A
  • exp. date 11/2019 Lot # VMSA17016-A
  • exp. date 11/2019 Lot # VMSA17017-A
  • exp. date 11/2019

UPCs (2)

  • 0365862739308
  • 0365862737304

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 10 recalled by Aurobindo Pharma USA 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 10 products in this recall →

Related recalls

Same brand · AMLODIPINE AND VALSARTAN

Same manufacturer · Aurobindo Pharma USA Inc.

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Same hazard · nde contamination

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