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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Sciegen Pharmaceuticals Inc: Irbesartan Blood Pressure Tablets Recalled for Potential Carcinogen Impurity

Agency Publication Date: November 20, 2018
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Summary

ScieGen Pharmaceuticals Inc. is recalling 66,816 bottles of Irbesartan (75 mg, 150 mg, and 300 mg) tablets sold under the Westminster Pharmaceuticals and GSMS brands. This recall was initiated after FDA testing confirmed the presence of N-nitrosodimethylamine (NDEA), an impurity that is classified as a probable human carcinogen. These prescription medications are used to treat high blood pressure and help protect kidneys in certain patients with diabetes. Consumers should not stop taking their medication without first consulting their doctor, as the risk of stopping blood pressure treatment could be higher than the risk of exposure to the impurity.

Risk

The tablets contain a chemical impurity called NDEA, which is a known environmental contaminant and is considered a probable human carcinogen. Long-term exposure to levels of NDEA above acceptable limits may increase the risk of developing cancer.

What You Should Do

  1. Check your prescription bottle for the following brand names and NDC numbers: Westminster Pharmaceuticals (69367-119-01, 69367-119-03, 69367-120-01, 69367-120-03, 69367-121-01, 69367-121-03) or GSMS Incorporated (60429-640-90, 60429-641-30, 60429-641-90, 60429-642-30, 60429-642-90).
  2. Verify the lot number and expiration date on the side of the bottle. Specifically look for Westminster lot B160002A (Exp Sep-19), B161005A (Exp Sep-19), C161002A (Exp Feb-20), B162008A (Exp Sep-19), and GSMS lots such as GS019526 (Exp Nov-19), GS020252 (Exp Nov-19), and GS022234 (Exp Feb-20) among others listed in the product details.
  3. Do NOT stop taking your medication immediately. Abruptly stopping Irbesartan can cause a dangerous spike in blood pressure. Contact your healthcare provider or pharmacist right away to discuss an alternative treatment or replacement.
  4. Contact the pharmacy where you purchased the medication to arrange for a return and potential refund of any unused portions of the affected lots.
  5. Contact ScieGen Pharmaceuticals Inc. or the respective marketers (Westminster or GSMS) for further instructions regarding this recall.
  6. 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

๐Ÿ’ฐFull Refund

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

How to: Consumers should contact their doctor or pharmacist for a replacement medication before returning the recalled product to the place of purchase.

Affected Products

Product: Westminster Irbesartan Tablets, USP, 75 mg (30 and 90-count bottles)
Model:
NDC 69367-119-01
NDC 69367-119-03
Lot Numbers:
B160002A (Exp Sep-19)
B160002B (Exp Sep-19)
Date Ranges: Expiration September 2019
Product: Westminster Irbesartan Tablets, USP, 150 mg (30 and 90-count bottles)
Model:
NDC 69367-120-01
NDC 69367-120-03
Lot Numbers:
B161005A (Exp Sep-19)
C161002A (Exp Feb-20)
B161005B (Exp Sep-19)
C161002B (Exp Feb-20)
Date Ranges: Expiration September 2019, Expiration February 2020
Product: Westminster Irbesartan Tablets, USP, 300 mg (30 and 90-count bottles)
Model:
NDC 69367-121-01
NDC 69367-121-03
Lot Numbers:
B162008A (Exp Sep-19)
C162002A (Exp Feb-20)
B162008B (Exp Sep-19)
C162002B (Exp Feb-20)
Date Ranges: Expiration September 2019, Expiration February 2020
Product: GSMS Irbesartan Tablets, USP, 75 mg (90-count bottle)
Model:
NDC 60429-640-90
Lot Numbers:
B160003 (Exp Sep-19)
B160004 (Exp Sep-19)
Date Ranges: Expiration September 2019
Product: GSMS Irbesartan Tablets, USP, 150 mg (30 and 90-count bottles)
Model:
NDC 60429-641-30
NDC 60429-641-90
Lot Numbers:
B161003 (Exp Sep-19)
B161004 (Exp Sep-19)
B161006 (Exp Sep-19)
B161007 (Exp Sep-19)
B161008 (Exp Nov-19)
B161009 (Exp Nov-19)
B161010 (Exp Nov-19)
C161001 (Exp Feb-20)
C161003 (Exp May-20)
GS019526 (Exp Nov-19)
GS020252 (Exp Nov-19)
GS020958 (Exp Nov-19)
Date Ranges: Expiration September 2019, Expiration November 2019, Expiration February 2020, Expiration May 2020
Product: GSMS Irbesartan Tablets, USP, 300 mg (30 and 90-count bottles)
Model:
NDC 60429-642-30
NDC 60429-642-90
Lot Numbers:
GS019036 (Exp Sep-19)
GS019073 (Exp Sep-19)
GS021472 (Exp Nov-19)
GS021530 (Exp Nov-19)
GS022234 (Exp Feb-20)
B162009 (Exp Sep-19)
B162010 (Exp Sep-19)
B162011 (Exp Sep-19)
B162012 (Exp Nov-19)
B162013 (Exp Nov-19)
B162014 (Exp Nov-19)
B162015 (Exp Nov-19)
C162001 (Exp Feb-20)
Date Ranges: Expiration September 2019, Expiration November 2019, Expiration February 2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81458
Status: Resolved
Manufacturer: Sciegen Pharmaceuticals Inc
Sold By: Westminster Pharmaceuticals LLC; GSMS Incorporated
Manufactured In: United States
Units Affected: 6 products (2,977 HDPE bottles; 5,061 HDPE bottles; 5,989 HDPE; 3,835 HDPE bottles; 18,760 HDPE bottles; 30,194 HDPE 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.

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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 ยท 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.