Medications & Supplements/Prescription Drugs

Golden State Medical Supply Inc.: Losartan Potassium Tablets Recalled for Impurity Presence

Agency Publication Date: April 13, 2020

Summary

Golden State Medical Supply Inc. is voluntarily recalling several lots of Losartan Potassium Tablets USP (25 mg) because a chemical impurity called N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) was detected in the active ingredient. This medication is used to treat high blood pressure. Consumers should not stop taking their medication before speaking with a healthcare professional, as the risk of stopping suddenly may outweigh the risk of exposure to the impurity.

Risk

The active ingredient used to manufacture these tablets contained NBMA, which is a substance that could potentially increase the risk of cancer over long-term exposure. No specific reports of illness or adverse events have been confirmed related to this recall.

What You Should Do

Check your prescription bottle for Losartan Potassium Tablets, USP, 25 mg with the following NDC numbers: 60429-316-30 (30 ct.), 60429-316-90 (90 ct.), or 60429-316-10 (1,000 ct.).
Verify if your bottle matches one of the following lot numbers and expiration dates: GS018406 (Exp. 6/30/2020), GS018858 (Exp. 7/31/2020), GS019108 (Exp. 7/31/2020), GS018521 (Exp. 7/31/2020), GS018605 (Exp. 7/31/2020), or GS018911 (Exp. 7/31/2020).
Contact your healthcare provider or pharmacist for guidance before you stop taking the medication, as suddenly stopping blood pressure treatment can be dangerous.
Return any unused product from the affected lots to your pharmacy for a refund and to discuss a replacement prescription.
Contact Golden State Medical Supply Inc. or the manufacturer for further instructions regarding the return process.
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

Full Refund

Consultation 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: Losartan Potassium Tablets, USP, 25 mg (30 ct. bottle)

Model:

NDC 60429-316-30

Lot Numbers:

GS018406 (Exp. 6/30/2020)

GS018858 (Exp. 7/31/2020)

GS019108 (Exp. 7/31/2020)

GS018521 (Exp. 7/31/2020)

GS018605 (Exp. 7/31/2020)

GS018911 (Exp. 7/31/2020)

Date Ranges: Expiration Date 6/30/2020, Expiration Date 7/31/2020

Product: Losartan Potassium Tablets, USP, 25 mg (90 ct. bottle)

Model:

NDC 60429-316-90

Lot Numbers:

GS018406 (Exp. 6/30/2020)

GS018858 (Exp. 7/31/2020)

GS019108 (Exp. 7/31/2020)

GS018521 (Exp. 7/31/2020)

GS018605 (Exp. 7/31/2020)

GS018911 (Exp. 7/31/2020)

Date Ranges: Expiration Date 6/30/2020, Expiration Date 7/31/2020

Product: Losartan Potassium Tablets, USP, 25 mg (1,000 ct. bottle)

Model:

NDC 60429-316-10

Lot Numbers:

GS018406 (Exp. 6/30/2020)

GS018858 (Exp. 7/31/2020)

GS019108 (Exp. 7/31/2020)

GS018521 (Exp. 7/31/2020)

GS018605 (Exp. 7/31/2020)

GS018911 (Exp. 7/31/2020)

Date Ranges: Expiration Date 6/30/2020, Expiration Date 7/31/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85401

Status: Resolved

Manufacturer: Golden State Medical Supply Inc.

Sold By: Pharmacies

Manufactured In: United States, Malta

Distributed To: Nationwide

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 for Losartan Potassium Tablets, USP, 25 mg with the following NDC numbers: 60429-316-30 (30 ct.), 60429-316-90 (90 ct.), or 60429-316-10 (1,000 ct.).

Verify if your bottle matches one of the following lot numbers and expiration dates: GS018406 (Exp. 6/30/2020), GS018858 (Exp. 7/31/2020), GS019108 (Exp. 7/31/2020), GS018521 (Exp. 7/31/2020), GS018605 (Exp. 7/31/2020), or GS018911 (Exp. 7/31/2020).

Contact your healthcare provider or pharmacist for guidance before you stop taking the medication, as suddenly stopping blood pressure treatment can be dangerous.

Return any unused product from the affected lots to your pharmacy for a refund and to discuss a replacement prescription.

Contact Golden State Medical Supply Inc. or the manufacturer for further instructions regarding the return process.

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.

Affected Products

Product: Losartan Potassium Tablets, USP, 25 mg (30 ct. bottle)

Model:

NDC 60429-316-30

Lot Numbers:

GS018406 (Exp. 6/30/2020)

GS018858 (Exp. 7/31/2020)

GS019108 (Exp. 7/31/2020)

GS018521 (Exp. 7/31/2020)

GS018605 (Exp. 7/31/2020)

GS018911 (Exp. 7/31/2020)

Date Ranges: Expiration Date 6/30/2020, Expiration Date 7/31/2020

Product: Losartan Potassium Tablets, USP, 25 mg (90 ct. bottle)

Model:

NDC 60429-316-90

Lot Numbers:

GS018406 (Exp. 6/30/2020)

GS018858 (Exp. 7/31/2020)

GS019108 (Exp. 7/31/2020)

GS018521 (Exp. 7/31/2020)

GS018605 (Exp. 7/31/2020)

GS018911 (Exp. 7/31/2020)

Date Ranges: Expiration Date 6/30/2020, Expiration Date 7/31/2020

Product: Losartan Potassium Tablets, USP, 25 mg (1,000 ct. bottle)

Model:

NDC 60429-316-10

Lot Numbers:

GS018406 (Exp. 6/30/2020)

GS018858 (Exp. 7/31/2020)

GS019108 (Exp. 7/31/2020)

GS018521 (Exp. 7/31/2020)

GS018605 (Exp. 7/31/2020)

GS018911 (Exp. 7/31/2020)

Date Ranges: Expiration Date 6/30/2020, Expiration Date 7/31/2020