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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Mylan Pharmaceuticals Inc.: Valsartan and Amlodipine Tablets Recalled for Potential NDEA Impurity

Agency Publication Date: December 11, 2018
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Summary

Mylan Pharmaceuticals Inc. has voluntarily recalled 215,685 bottles of various Valsartan-containing medications, including Amlodipine and Valsartan (generic Exforge), Valsartan (generic Diovan), and Valsartan and Hydrochlorothiazide (generic Diovan HCT). These medications, used to treat high blood pressure and heart failure, were found to contain an impurity called N-nitrosodiethylamine (NDEA). This impurity was detected in the active ingredient manufactured in India and is classified as a probable human carcinogen. To date, no injuries or adverse events have been reported specifically related to this recall.

Risk

The medications contain N-nitrosodiethylamine (NDEA), a substance that occurs naturally in certain foods and drinking water but is classified as a probable human carcinogen. Long-term exposure to levels above safety limits may increase the risk of cancer.

What You Should Do

  1. Identify if your medication is affected by checking the bottle for the following product names and NDC numbers: Amlodipine and Valsartan (NDC 0378-1721-93, 0378-1722-93, 0378-1724-93), Valsartan (NDC 0378-5813-77, 0378-5814-77, 0378-5807-93, 0378-5815-77), or Valsartan and Hydrochlorothiazide (NDC 0378-6325-05).
  2. Verify the lot number and expiration date on your bottle against the recalled list, which includes lots such as 3066051 (Exp. 3/2019), 3079500 (Exp. 1/2020), 3063782 (Exp. 1/2019), 3071352 (Exp. 7/2019), 3061169 (Exp. 11/2018), 3081499, 3080009, 3080010, 3079205 (Exp. 1/2020 to 3/2020), 3084886 (Exp. 2/2019), 3093804 (Exp. 12/2019), 3061986 (Exp. 11/2018), 3079709, 3077618, and 3079708 (Exp. 11/2019 to 1/2020).
  3. Do NOT stop taking your medication without first consulting your doctor or pharmacist, as the risk of suddenly stopping blood pressure treatment may be greater than the risk of the impurity.
  4. Contact your healthcare provider or pharmacist for guidance on obtaining a replacement or an alternative treatment if your lot is affected.
  5. Return any unused portions of the affected medication to your pharmacy for a refund and contact Mylan Pharmaceuticals at 781 Chestnut Ridge Rd, Morgantown, WV for further manufacturer instructions.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug replacement and refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg (30-count bottle)
Model:
NDC 0378-1721-93
Lot Numbers:
3066051 (Exp. 3/2019)
Date Ranges: Expiration date 3/2019
Product: Amlodipine and Valsartan Tablets, USP, 10 mg/160 mg (30-count bottle)
Model:
NDC 0378-1722-93
Lot Numbers:
3079500 (Exp. 1/2020)
Date Ranges: Expiration date 1/2020
Product: Valsartan Tablets, USP, 80 mg (90-count bottle)
Model:
NDC 0378-5813-77
Lot Numbers:
3063782 (Exp. 1/2019)
Date Ranges: Expiration date 1/2019
Product: Valsartan Tablets, USP, 160 mg (90-count bottle)
Model:
NDC 0378-5814-77
Lot Numbers:
3071352 (Exp. 7/2019)
Date Ranges: Expiration date 7/2019
Product: Valsartan Tablets, USP, 40 mg (30-count bottle)
Model:
NDC 0378-5807-93
Lot Numbers:
3061169 (Exp. 11/2018)
Date Ranges: Expiration date 11/2018
Product: Valsartan Tablets, USP, 320 mg (90-count bottle)
Model:
NDC 0378-5815-77
Lot Numbers:
3081499 (Exp. 3/2020)
3080009 (Exp. 2/2020)
3080010 (Exp. 2/2020)
3079205 (Exp. 1/2020)
Date Ranges: Expiration dates 1/2020 to 3/2020
Product: Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg (500-count bottle)
Model:
NDC 0378-6325-05
Lot Numbers:
3084886 (Exp. 2/2019)
3093804 (Exp. 12/2019)
Date Ranges: Expiration dates 2/2019 to 12/2019
Product: Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg (30-count bottle)
Model:
NDC 0378-1724-93
Lot Numbers:
3061986 (Exp. 11/2018)
3079709 (Exp. 1/2020)
3077618 (Exp. 11/2019)
3079708 (Exp. 1/2020)
Date Ranges: Expiration dates 11/2018 to 1/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81613
Status: Active
Manufacturer: Mylan Pharmaceuticals Inc.
Sold By: Pharmacies; Healthcare providers
Manufactured In: India, United States
Units Affected: 8 products (23,478 bottles; 12,336 bottles; 24,709 bottles; 12,840 bottles; 63,213 bottles; 25,147 bottles; 5,660 bottles; 48,302 bottles)
Distributed To: Nationwide
Agency Last Updated: December 14, 2018

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.