Medications & Supplements/Prescription Drugs

Bryant Ranch Prepack Inc.: Valsartan Tablets Recalled Due to Carcinogen Impurity

Agency Publication Date: August 2, 2018

Summary

Bryant Ranch Prepack Inc. is recalling approximately 1,770 units of Valsartan 80 mg and 320 mg tablets because a cancer-causing impurity was found in the active ingredient used to make the medication. This recall involves 90, 60, and 28-count bottles of the 80 mg strength, and 90, 30, and 28-count bottles of the 320 mg strength. These prescription medications were distributed in Florida, Indiana, and Hawaii. Consumers should not stop taking their medication without first consulting a healthcare provider, as the risk of stopping the drug immediately may outweigh the risk of the impurity.

Risk

The active pharmaceutical ingredient (API) used to manufacture these tablets was found to contain a nitrosamine impurity, which is classified as a probable human carcinogen. Long-term exposure to this substance may increase the risk of developing cancer.

What You Should Do

Check your prescription bottle to see if you have Valsartan 80 mg tablets (90-count NDC 63629-6922-2, 60-count NDC 63629-6922-3, or 28-count NDC 63629-6922-4) with Lot # 111158 and expiration date 02/19.
Check if you have Valsartan 320 mg tablets (30-count NDC 63629-6905-1, 90-count NDC 63629-6905-2, or 28-count NDC 6362-96905-3) with Lot # 114319 (Exp. 10/18) or Lot # 109004 (Exp. 12/18).
Check if you have Valsartan 320 mg tablets in 90-count bottles (NDC 71335-0567-2) with Lot # 120879 and expiration date 10/19.
Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement or alternative medication before you stop taking the recalled tablets.
Return any unused recalled product to the pharmacy where you purchased it for a refund.
Contact Bryant Ranch Prepack Inc. at their Burbank, CA location for further instructions regarding this recall.
For additional information, you may 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

Healthcare consultation and pharmaceutical refund

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-count)

Model:

NDC 63629-6922-2

Lot Numbers:

111158 (Exp. 02/19)

Date Ranges: 02/19

Product: Valsartan 80 mg tablets (60-count)

Model:

NDC 63629-6922-3

Lot Numbers:

111158 (Exp. 02/19)

Date Ranges: 02/19

Product: Valsartan 80 mg tablets (28-count)

Model:

NDC 63629-6922-4

Lot Numbers:

111158 (Exp. 02/19)

Date Ranges: 02/19

Product: Valsartan 320 mg tablets (30-count)

Model:

NDC 63629-6905-1

Lot Numbers:

114319 (Exp. 10/18)

109004 (Exp. 12/18)

Date Ranges: 10/18, 12/18

Product: Valsartan 320 mg tablets (90-count)

Model:

NDC 63629-6905-2

Lot Numbers:

114319 (Exp. 10/18)

109004 (Exp. 12/18)

Date Ranges: 10/18, 12/18

Product: Valsartan 320 mg tablets (28-count)

Model:

NDC 6362-96905-3

Lot Numbers:

114319 (Exp. 10/18)

109004 (Exp. 12/18)

Date Ranges: 10/18, 12/18

Product: Valsartan 320 mg tablets (90-count)

Model:

NDC 71335-0567-2

Lot Numbers:

120879 (Exp 10/19)

Date Ranges: 10/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80634

Status: Resolved

Manufacturer: Bryant Ranch Prepack Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 3 products (690 tablets; 990 tablets; 90 tablets)

Distributed To: Hawaii, Indiana, Florida

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 prescription bottle to see if you have Valsartan 80 mg tablets (90-count NDC 63629-6922-2, 60-count NDC 63629-6922-3, or 28-count NDC 63629-6922-4) with Lot # 111158 and expiration date 02/19.

Check if you have Valsartan 320 mg tablets (30-count NDC 63629-6905-1, 90-count NDC 63629-6905-2, or 28-count NDC 6362-96905-3) with Lot # 114319 (Exp. 10/18) or Lot # 109004 (Exp. 12/18).

Check if you have Valsartan 320 mg tablets in 90-count bottles (NDC 71335-0567-2) with Lot # 120879 and expiration date 10/19.

Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement or alternative medication before you stop taking the recalled tablets.

Return any unused recalled product to the pharmacy where you purchased it for a refund.

Contact Bryant Ranch Prepack Inc. at their Burbank, CA location for further instructions regarding this recall.

For additional information, you may 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-count)

Model:

NDC 63629-6922-2

Lot Numbers:

111158 (Exp. 02/19)

Date Ranges: 02/19

Product: Valsartan 80 mg tablets (60-count)

Model:

NDC 63629-6922-3

Lot Numbers:

111158 (Exp. 02/19)

Date Ranges: 02/19

Product: Valsartan 80 mg tablets (28-count)

Model:

NDC 63629-6922-4

Lot Numbers:

111158 (Exp. 02/19)

Date Ranges: 02/19

Product: Valsartan 320 mg tablets (30-count)

Model:

NDC 63629-6905-1

Lot Numbers:

114319 (Exp. 10/18)

109004 (Exp. 12/18)

Date Ranges: 10/18, 12/18

Product: Valsartan 320 mg tablets (90-count)

Model:

NDC 63629-6905-2

Lot Numbers:

114319 (Exp. 10/18)

109004 (Exp. 12/18)

Date Ranges: 10/18, 12/18

Product: Valsartan 320 mg tablets (28-count)

Model:

NDC 6362-96905-3

Lot Numbers:

114319 (Exp. 10/18)

109004 (Exp. 12/18)

Date Ranges: 10/18, 12/18

Product: Valsartan 320 mg tablets (90-count)

Model:

NDC 71335-0567-2

Lot Numbers:

120879 (Exp 10/19)

Date Ranges: 10/19