Medications & Supplements/Prescription Drugs

RemedyRepack Inc.: Amlodipine/Valsartan HCTZ Recalled for Potential NDMA Impurity

Agency Publication Date: October 24, 2018

Summary

RemedyRepack Inc. is recalling two bottles (180 tablets total) of Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg, a medication used to treat high blood pressure. This recall was initiated due to the detection of trace amounts of N-nitrosodimethylamine (NDMA) within the active pharmaceutical ingredient. NDMA is classified as a probable human carcinogen, meaning it is a substance that could cause cancer based on laboratory tests. These specific bottles were distributed to a medical facility in South Carolina.

Risk

The medication contains trace amounts of NDMA, an impurity that is linked to an increased risk of cancer with long-term exposure. No injuries or adverse events have been reported specifically for these two units.

What You Should Do

Check your medication bottle for Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets with Repackaged NDC 70518-1220-00 and Lot number B0438903-052118.
Identify if your bottle is an HDPE 90 cc bottle containing 90 tablets, which may have been delivered in cardboard trays.
Do not stop taking your blood pressure medication without first talking to your doctor or pharmacist, as the risk of suddenly stopping high blood pressure treatment can be more dangerous than the potential exposure to the impurity.
Contact your healthcare provider or pharmacist immediately to discuss an alternative treatment or to arrange for a replacement for the affected lot.
Return any unused tablets from Lot B0438903-052118 to the medical facility where you received them for a refund and contact RemedyRepack Inc. at their Indiana, Pennsylvania location for further guidance.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact healthcare provider or pharmacist and return product.

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

Affected Products

Product: Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets (90-count bottle)

Model:

Original NDC 13668-0325-30

Repackaged NDC 70518-1220-00

Recall #: D-0093-2019

Lot Numbers:

B0438903-052118

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81395

Status: Resolved

Manufacturer: RemedyRepack Inc.

Sold By: Medical facility in South Carolina

Manufactured In: United States

Units Affected: 2 bottles of 90 tablets (180 tablets)

Distributed To: South Carolina

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 · 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.

Summary

What You Should Do

Check your medication bottle for Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets with Repackaged NDC 70518-1220-00 and Lot number B0438903-052118.

Identify if your bottle is an HDPE 90 cc bottle containing 90 tablets, which may have been delivered in cardboard trays.

Do not stop taking your blood pressure medication without first talking to your doctor or pharmacist, as the risk of suddenly stopping high blood pressure treatment can be more dangerous than the potential exposure to the impurity.

Contact your healthcare provider or pharmacist immediately to discuss an alternative treatment or to arrange for a replacement for the affected lot.

Return any unused tablets from Lot B0438903-052118 to the medical facility where you received them for a refund and contact RemedyRepack Inc. at their Indiana, Pennsylvania location for further guidance.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.