🔍 RecallPedia

Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo Pharma Limited, India --- NDC 65862-739-30

Class I - Dangerous
💊 Drugs Recalled: December 31, 2018 Aurobindo Pharma USA Prescription Drugs

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: VFSA17007-A, exp. date Oct-2019
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Aurobindo Pharma USA Inc.
Reason for Recall:
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo Pharma Limited, India --- NDC 65862-739-30

Product Codes/Lot Numbers:

Lot Numbers: VFSA17007-A, exp. date Oct-2019

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1036-2019

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