Medications & Supplements/Prescription Drugs

Golden State Medical Supply Inc.: Irbesartan Blood Pressure Tablets Recalled for Impurity (NDEA)

Agency Publication Date: November 20, 2018

Summary

Golden State Medical Supply is recalling approximately 30,858 bottles of Irbesartan (75 mg, 150 mg, and 300 mg tablets), a medication used to treat high blood pressure. FDA laboratory testing discovered the presence of an impurity called N-nitrosodiethylamine (NDEA) in the product, which was manufactured by SciGen Pharmaceuticals. This recall affects various 30-count and 90-count bottles sold across the United States. Consumers should not stop taking their medication without first consulting a healthcare professional, as the risk to their health may be higher if the treatment is stopped immediately without an alternative.

Risk

The tablets contain N-nitrosodiethylamine (NDEA), a substance that is classified as a probable human carcinogen. Long-term exposure to this impurity above acceptable levels may increase the risk of cancer.

What You Should Do

Check your prescription bottle for the product name Irbesartan Tablets, USP and the NDC numbers 60429-640-90 (75 mg), 60429-641-30 or 60429-641-90 (150 mg), or 60429-642-30 or 60429-642-90 (300 mg).
Verify if your lot number and expiration date match the affected products: for 75 mg check lots B160003 or B160004 (Exp. 09/19); for 150 mg check 30-count lots GS019526, GS020252, GS020958 (Exp. 11/19) or 90-count lots B161003 through B161010, C161001, and C161003; for 300 mg check 30-count lots GS019036, GS019073, GS021472, GS021530, GS022234 or 90-count lots B162009 through B162015 and C162001.
Contact your healthcare provider or pharmacist immediately to discuss an alternative treatment before you stop taking the recalled medication.
Return any unused portions of the recalled medication to your pharmacy for a refund and contact Golden State Medical Supply at 1-800-284-8633 for further instructions.
Report any adverse reactions or quality problems to the FDA's MedWatch Adverse Event Reporting program at 1-800-332-1088.
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

Drug recall standard remedy

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

Affected Products

Product: IRBESARTAN Tablets, USP 75 mg (90-count bottle)

Model:

NDC 60429-640-90

Recall #: D-0263-2019

Lot Numbers:

B160003 (Exp. 09/19)

B160004 (Exp. 09/19)

Date Ranges: Expiration 09/19

Product: IRBESARTAN Tablets, USP 150 mg (30-count bottle)

Model:

NDC 60429-641-30

Recall #: D-0264-2019

Lot Numbers:

GS019526 (Exp. 11/19)

GS020252 (Exp. 11/19)

GS020958 (Exp. 11/19)

Date Ranges: Expiration 11/19

Product: IRBESARTAN Tablets, USP 150 mg (90-count bottle)

Model:

NDC 60429-641-90

Recall #: D-0264-2019

Lot Numbers:

B161003 (Exp. 09/19)

B161004 (Exp. 09/19)

B161006 (Exp. 09/19)

B161007 (Exp. 09/19)

B161008 (Exp. 11/19)

B161009 (Exp. 11/19)

B161010 (Exp. 11/19)

C161001 (Exp. 02/20)

C161003 (Exp. 05/20)

Date Ranges: Expiration 09/19, Expiration 11/19, Expiration 02/20, Expiration 05/20

Product: IRBESARTAN Tablets, USP 300 mg (30-count bottle)

Model:

NDC 60429-642-30

Recall #: D-0265-2019

Lot Numbers:

GS019036 (Exp. 09/19)

GS019073 (Exp. 09/19)

GS021472 (Exp. 11/19)

GS021530 (Exp. 11/19)

GS022234 (Exp. 02/20)

Date Ranges: Expiration 09/19, Expiration 11/19, Expiration 02/20

Product: IRBESARTAN Tablets, USP 300 mg (90-count bottle)

Model:

NDC 60429-642-90

Recall #: D-0265-2019

Lot Numbers:

B162009 (Exp. 09/19)

B162010 (Exp. 09/19)

B162011 (Exp. 09/19)

B162012 (Exp. 11/19)

B162013 (Exp. 11/19)

B162014 (Exp. 11/19)

B162015 (Exp. 11/19)

C162001 (Exp. 02/20)

Date Ranges: Expiration 09/19, Expiration 11/19, Expiration 02/20

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81500

Status: Resolved

Manufacturer: Golden State Medical Supply Inc.

Sold By: Pharmacies; Hospitals

Manufactured In: United States

Units Affected: 3 products (2,439 bottles; 15,917 bottles; 12,502 bottles)

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 the product name Irbesartan Tablets, USP and the NDC numbers 60429-640-90 (75 mg), 60429-641-30 or 60429-641-90 (150 mg), or 60429-642-30 or 60429-642-90 (300 mg).

Verify if your lot number and expiration date match the affected products: for 75 mg check lots B160003 or B160004 (Exp. 09/19); for 150 mg check 30-count lots GS019526, GS020252, GS020958 (Exp. 11/19) or 90-count lots B161003 through B161010, C161001, and C161003; for 300 mg check 30-count lots GS019036, GS019073, GS021472, GS021530, GS022234 or 90-count lots B162009 through B162015 and C162001.

Contact your healthcare provider or pharmacist immediately to discuss an alternative treatment before you stop taking the recalled medication.

Return any unused portions of the recalled medication to your pharmacy for a refund and contact Golden State Medical Supply at 1-800-284-8633 for further instructions.

Report any adverse reactions or quality problems to the FDA's MedWatch Adverse Event Reporting program at 1-800-332-1088.

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

Affected Products

Product: IRBESARTAN Tablets, USP 75 mg (90-count bottle)

Model:

NDC 60429-640-90

Recall #: D-0263-2019

Lot Numbers:

B160003 (Exp. 09/19)

B160004 (Exp. 09/19)

Date Ranges: Expiration 09/19

Product: IRBESARTAN Tablets, USP 150 mg (30-count bottle)

Model:

NDC 60429-641-30

Recall #: D-0264-2019

Lot Numbers:

GS019526 (Exp. 11/19)

GS020252 (Exp. 11/19)

GS020958 (Exp. 11/19)

Date Ranges: Expiration 11/19

Product: IRBESARTAN Tablets, USP 150 mg (90-count bottle)

Model:

NDC 60429-641-90

Recall #: D-0264-2019

Lot Numbers:

B161003 (Exp. 09/19)

B161004 (Exp. 09/19)

B161006 (Exp. 09/19)

B161007 (Exp. 09/19)

B161008 (Exp. 11/19)

B161009 (Exp. 11/19)

B161010 (Exp. 11/19)

C161001 (Exp. 02/20)

C161003 (Exp. 05/20)

Date Ranges: Expiration 09/19, Expiration 11/19, Expiration 02/20, Expiration 05/20

Product: IRBESARTAN Tablets, USP 300 mg (30-count bottle)

Model:

NDC 60429-642-30

Recall #: D-0265-2019

Lot Numbers:

GS019036 (Exp. 09/19)

GS019073 (Exp. 09/19)

GS021472 (Exp. 11/19)

GS021530 (Exp. 11/19)

GS022234 (Exp. 02/20)

Date Ranges: Expiration 09/19, Expiration 11/19, Expiration 02/20

Product: IRBESARTAN Tablets, USP 300 mg (90-count bottle)

Model:

NDC 60429-642-90

Recall #: D-0265-2019

Lot Numbers:

B162009 (Exp. 09/19)

B162010 (Exp. 09/19)

B162011 (Exp. 09/19)

B162012 (Exp. 11/19)

B162013 (Exp. 11/19)

B162014 (Exp. 11/19)

B162015 (Exp. 11/19)

C162001 (Exp. 02/20)

Date Ranges: Expiration 09/19, Expiration 11/19, Expiration 02/20