Medications & Supplements/Prescription Drugs

RemedyRepack Inc.: Valsartan Tablets Recalled for Potential Carcinogen Impurity

Agency Publication Date: August 17, 2018

Summary

RemedyRepack Inc. is recalling 66 bottles (totaling 5,940 tablets) of Valsartan in 80 mg, 160 mg, and 320 mg strengths. This recall was initiated because the active pharmaceutical ingredient (API) used to manufacture the tablets was found to contain a nitrosamine impurity, which is classified as a possible human carcinogen. These prescription medications are used to treat high blood pressure and heart failure, and were distributed in white plastic bottles within cardboard trays to customers in Florida and Virginia.

Risk

The tablets contain an impurity that is linked to an increased risk of cancer. While there have been no reported injuries or adverse events at this time, the presence of this impurity deviates from safe manufacturing standards.

What You Should Do

Check your medication bottle for the following product names and NDC numbers: Valsartan 80 mg (NDC 61786-0791-19), Valsartan 160 mg (NDC 61786-0792-19), or Valsartan 320 mg (NDC 61786-0793-19).
Verify the lot numbers and expiration dates on the packaging. For 80 mg and 160 mg tablets, look for lots B0335344-081717 (Exp 08/2018), B0363364-110917 (Exp 11/2018), B0391225-012218 (Exp 01/2019), B0408458-030618 (Exp 03/2019), B0384871-010318 (Exp 01/2019), or B0436862-051518 (Exp 05/2019).
For 320 mg tablets, check for lots B0362988-110917 (Exp 10/2018), B0432265-050318 (Exp 05/2019), B0450321-061218 (Exp 06/2019), B0450322-061218 (Exp 05/2019), or B0408652-030718 (Exp 02/2019).
Contact your healthcare provider or pharmacist immediately for guidance before you stop taking the medication, as suddenly stopping blood pressure treatment can pose health risks.
Return any unused or remaining medication to the pharmacy where it was purchased for a refund and contact RemedyRepack Inc. at their facility at 625 Kolter Drive, Suite 4, Indiana, PA 15701 for further instructions.
For additional questions or to report a complaint, 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 and return product to pharmacy.

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

Affected Products

Product: Valsartan 80 mg Tablets (90 cc bottle)

Model:

NDC 61786-0791-19

Lot Numbers:

B0335344-081717 (Exp 08/2018)

B0363364-110917 (Exp 11/2018)

B0391225-012218 (Exp 01/2019)

B0408458-030618 (Exp 03/2019)

B0384871-010318 (Exp 01/2019)

B0436862-051518 (Exp 05/2019)

Date Ranges: 08/2018, 11/2018, 01/2019, 03/2019, 05/2019

Product: Valsartan 160 mg Tablets (90 cc bottle)

Model:

NDC 61786-0792-19

Lot Numbers:

B0335344-081717 (Exp 08/2018)

B0363364-110917 (Exp 11/2018)

B0391225-012218 (Exp 01/2019)

B0408458-030618 (Exp 03/2019)

B0384871-010318 (Exp 01/2019)

B0436862-051518 (Exp 05/2019)

Date Ranges: 08/2018, 11/2018, 01/2019, 03/2019, 05/2019

Product: Valsartan 320 mg Tablets (90 cc bottle)

Model:

NDC 61786-0793-19

Lot Numbers:

B0362988-110917 (Exp 10/2018)

B0432265-050318 (Exp 05/2019)

B0450321-061218 (Exp 06/2019)

B0450322-061218 (Exp 05/2019)

B0408652-030718 (Exp 02/2019)

Date Ranges: 10/2018, 05/2019, 06/2019, 02/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80827

Status: Resolved

Manufacturer: RemedyRepack Inc.

Manufactured In: United States

Units Affected: 3 products (9 bottles of 90 = 810 tablets; 21 bottles of 90 = 1890 tablets; 36 bottles of 90 = 3240 tablets)

Distributed To: Florida, Virginia

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 the following product names and NDC numbers: Valsartan 80 mg (NDC 61786-0791-19), Valsartan 160 mg (NDC 61786-0792-19), or Valsartan 320 mg (NDC 61786-0793-19).

Verify the lot numbers and expiration dates on the packaging. For 80 mg and 160 mg tablets, look for lots B0335344-081717 (Exp 08/2018), B0363364-110917 (Exp 11/2018), B0391225-012218 (Exp 01/2019), B0408458-030618 (Exp 03/2019), B0384871-010318 (Exp 01/2019), or B0436862-051518 (Exp 05/2019).

For 320 mg tablets, check for lots B0362988-110917 (Exp 10/2018), B0432265-050318 (Exp 05/2019), B0450321-061218 (Exp 06/2019), B0450322-061218 (Exp 05/2019), or B0408652-030718 (Exp 02/2019).

Contact your healthcare provider or pharmacist immediately for guidance before you stop taking the medication, as suddenly stopping blood pressure treatment can pose health risks.

Return any unused or remaining medication to the pharmacy where it was purchased for a refund and contact RemedyRepack Inc. at their facility at 625 Kolter Drive, Suite 4, Indiana, PA 15701 for further instructions.

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

Affected Products

Product: Valsartan 80 mg Tablets (90 cc bottle)

Model:

NDC 61786-0791-19

Lot Numbers:

B0335344-081717 (Exp 08/2018)

B0363364-110917 (Exp 11/2018)

B0391225-012218 (Exp 01/2019)

B0408458-030618 (Exp 03/2019)

B0384871-010318 (Exp 01/2019)

B0436862-051518 (Exp 05/2019)

Date Ranges: 08/2018, 11/2018, 01/2019, 03/2019, 05/2019

Product: Valsartan 160 mg Tablets (90 cc bottle)

Model:

NDC 61786-0792-19

Lot Numbers:

B0335344-081717 (Exp 08/2018)

B0363364-110917 (Exp 11/2018)

B0391225-012218 (Exp 01/2019)

B0408458-030618 (Exp 03/2019)

B0384871-010318 (Exp 01/2019)

B0436862-051518 (Exp 05/2019)

Date Ranges: 08/2018, 11/2018, 01/2019, 03/2019, 05/2019

Product: Valsartan 320 mg Tablets (90 cc bottle)

Model:

NDC 61786-0793-19

Lot Numbers:

B0362988-110917 (Exp 10/2018)

B0432265-050318 (Exp 05/2019)

B0450321-061218 (Exp 06/2019)

B0450322-061218 (Exp 05/2019)

B0408652-030718 (Exp 02/2019)

Date Ranges: 10/2018, 05/2019, 06/2019, 02/2019