Medications & Supplements/Prescription Drugs

Westminster Pharmaceuticals Llc: Irbesartan Tablets Recalled Due to NDEA Impurity

Agency Publication Date: December 11, 2018

Summary

Westminster Pharmaceuticals is recalling 7,866 bottles of Irbesartan (Irbesartan Tablets, USP) in 75 mg, 150 mg, and 300 mg strengths. The recall was initiated because FDA laboratory testing confirmed traces of N-Nitrosodiethylamine (NDEA), a substance classified as a probable human carcinogen, in specific lots. These prescription medications are used to treat high blood pressure and are packaged in 30-count and 90-count white plastic bottles. Consumers currently taking these medications should not stop until they have consulted with a healthcare professional to arrange for an alternative treatment.

Risk

The tablets contain NDEA, which is a chemical impurity known to potentially increase the risk of cancer with long-term exposure. While no immediate injuries have been reported, the presence of this impurity represents a violation of good manufacturing practices.

What You Should Do

Check your prescription bottle label to see if you have Westminster Irbesartan Tablets, USP in 75 mg, 150 mg, or 300 mg strengths.
For 75 mg tablets, look for NDC 69367-119-01 (30-count) or NDC 69367-119-03 (90-count) with batch numbers B160002A or B160002B (Exp. 09/30/2019).
For 150 mg tablets, look for NDC 69367-120-01 (30-count) or NDC 69367-120-03 (90-count) with batch numbers B161005A, C161002A, B161005B, or C161002B (Exp. 09/30/2019 or 02/29/2020).
For 300 mg tablets, look for NDC 69367-121-01 (30-count) or NDC 69367-121-03 (90-count) with batch numbers B162008A, C162002A, B162008B, or C162002B (Exp. 09/30/2019 or 02/29/2020).
Contact your healthcare provider or pharmacist immediately to discuss your treatment; it is dangerous to stop taking blood pressure medication suddenly without a replacement.
Return any unused tablets to your pharmacy for a refund and contact Westminster Pharmaceuticals for further instructions.
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

Healthcare provider consultation and pharmacy refund

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

Affected Products

Product: Westminster Irbesartan Tablets, USP 75 mg (30 count bottle)

Model:

NDC 69367-119-01

Lot Numbers:

B160002A (Exp. 09/30/2019)

Date Ranges: September 30, 2019

Product: Westminster Irbesartan Tablets, USP 75 mg (90 count bottle)

Model:

NDC 69367-119-03

Lot Numbers:

B160002B (Exp. 09/30/2019)

Date Ranges: September 30, 2019

Product: Westminster Irbesartan Tablets, USP 150 mg (30 count bottle)

Model:

NDC 69367-120-01

Lot Numbers:

B161005A (Exp. 09/30/2019)

C161002A (Exp. 02/29/2020)

Date Ranges: September 30, 2019, February 29, 2020

Product: Westminster Irbesartan Tablets, USP 150 mg (90 count bottle)

Model:

NDC 69367-120-03

Lot Numbers:

B161005B (Exp. 09/30/2019)

C161002B (Exp. 02/29/2020)

Date Ranges: September 30, 2019, February 29, 2020

Product: Westminster Irbesartan Tablets, USP 300 mg (30 count bottle)

Model:

NDC 69367-121-01

Lot Numbers:

B162008A (Exp. 09/30/2019)

C162002A (Exp. 02/29/2020)

Date Ranges: September 30, 2019, February 29, 2020

Product: Westminster Irbesartan Tablets, USP 300 mg (90 count bottle)

Model:

NDC 69367-121-03

Lot Numbers:

B162008B (Exp. 09/30/2019)

C162002B (Exp. 02/29/2020)

Date Ranges: September 30, 2019, February 29, 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81668

Status: Resolved

Manufacturer: Westminster Pharmaceuticals Llc

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 3 products (1571 bottles; 2319 bottles; 3976 bottles)

Distributed To: Nationwide

Agency Last Updated: December 14, 2018

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 label to see if you have Westminster Irbesartan Tablets, USP in 75 mg, 150 mg, or 300 mg strengths.

For 75 mg tablets, look for NDC 69367-119-01 (30-count) or NDC 69367-119-03 (90-count) with batch numbers B160002A or B160002B (Exp. 09/30/2019).

For 150 mg tablets, look for NDC 69367-120-01 (30-count) or NDC 69367-120-03 (90-count) with batch numbers B161005A, C161002A, B161005B, or C161002B (Exp. 09/30/2019 or 02/29/2020).

For 300 mg tablets, look for NDC 69367-121-01 (30-count) or NDC 69367-121-03 (90-count) with batch numbers B162008A, C162002A, B162008B, or C162002B (Exp. 09/30/2019 or 02/29/2020).

Contact your healthcare provider or pharmacist immediately to discuss your treatment; it is dangerous to stop taking blood pressure medication suddenly without a replacement.

Return any unused tablets to your pharmacy for a refund and contact Westminster Pharmaceuticals for further instructions.

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: Westminster Irbesartan Tablets, USP 75 mg (30 count bottle)

Model:

NDC 69367-119-01

Lot Numbers:

B160002A (Exp. 09/30/2019)

Date Ranges: September 30, 2019

Product: Westminster Irbesartan Tablets, USP 75 mg (90 count bottle)

Model:

NDC 69367-119-03

Lot Numbers:

B160002B (Exp. 09/30/2019)

Date Ranges: September 30, 2019

Product: Westminster Irbesartan Tablets, USP 150 mg (30 count bottle)

Model:

NDC 69367-120-01

Lot Numbers:

B161005A (Exp. 09/30/2019)

C161002A (Exp. 02/29/2020)

Date Ranges: September 30, 2019, February 29, 2020

Product: Westminster Irbesartan Tablets, USP 150 mg (90 count bottle)

Model:

NDC 69367-120-03

Lot Numbers:

B161005B (Exp. 09/30/2019)

C161002B (Exp. 02/29/2020)

Date Ranges: September 30, 2019, February 29, 2020

Product: Westminster Irbesartan Tablets, USP 300 mg (30 count bottle)

Model:

NDC 69367-121-01

Lot Numbers:

B162008A (Exp. 09/30/2019)

C162002A (Exp. 02/29/2020)

Date Ranges: September 30, 2019, February 29, 2020

Product: Westminster Irbesartan Tablets, USP 300 mg (90 count bottle)

Model:

NDC 69367-121-03

Lot Numbers:

B162008B (Exp. 09/30/2019)

C162002B (Exp. 02/29/2020)

Date Ranges: September 30, 2019, February 29, 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81668

Status: Resolved

Manufacturer: Westminster Pharmaceuticals Llc

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 3 products (1571 bottles; 2319 bottles; 3976 bottles)

Distributed To: Nationwide

Agency Last Updated: December 14, 2018