Overview
The recall affects Irbesartan and Irbesartan HCTZ, which New Jersey-based Prinston Pharmaceuticals pulled due to danger of contamination with N-nitrosodiethylamine, a suspected human carcinogen (cancer-causing substance). The substance was found in an ingredient manufactured by the Chinese company Zhejiang Huahai Pharmaceuticals. NDMA may have been in the following drugs for up to 4 years, FDA said.
Which Products are Affected?
The Irbesartan recall affects the following products, according to the FDA:
- Irbesartan tablets 300MG 90CT, NDC code 43547-376-09, Lot number 331B18009, Expiration date 02/2021.
- Irbesartan/HCTZ 300MG/12.5MG 30CT tablets, NDC code 43547-331-03, lot number 327A18001, expiration date 03/2021.
- Irbesartan Tablets/HCTZ 300MG/12.5MG 30 CT tablets, NDC code 43547-331-03, lot number 327A18002, expiration date 03/2021.
- Irbesartan Tablets/HCTZ 300MG/12.5MG 90CT tablets, NDC code 43547-331-09, lot number 327B18008, expiration date 03/2021.
- Irbesartan/HCTZ 300MG/12.5MG 90CT tablets, NDC code 43547-331-09, lot number 327B18009, expiration date 03/2021.
- Irbesartan/HCTZ 150MG/12.5MG 30CT, NDC code 43547-330-03, lot number 325D18004, expiration date 03/2021.
- Irbesartan/HCTZ 150MG/12.5MG 90CT tablets, NDC code 43547-330-09, lot number 325B18004, expiration date 03/2021.
- Irbesartan/HCTZ 150MG/12.5MG 30CT tablets, NDC code 43547-330-03, lot number 325D18005, expiration date 03/2021.
Irbesartan Side Effects
In addition to potentially increasing the risk of cancer, side effects of Irbesartan may include:
- Dizziness
- Lightheadedness
- Upset stomach
- Diarrhea
- Heartburn
- Tiredness
What is the Cancer Risk with NDMA?
Over the course of a lifetime, consuming 96 nanograms of NDMA would result in less than 1 additional case of cancer for every 100,000 people, FDA said. While this is a low overall risk for development of the disease, anything you can help to reduce your risk of cancer is highly advisable. In 2018, an estimated 1,735,350 new cases of cancer will be diagnosed in the U.S., and 609,640 people will die from the disease, according to the National Cancer Institute (NCI). Do all you can not to be one of these statistics.
Free Confidential Lawsuit Evaluation: Our lawyers are currently wishing to speak with anyone who has been harmed by side effects of Irbesartan. If you were diagnosed with cancer, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
Do I Have an Irbesartan Class Action Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Irbesartan lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Case Evaluation: Again, if you or a loved one has been injured by the side effects of Irbesartan, you should contact our law firm immediately. You may be entitled to a settlement by filing a class action suit and our lawyers can help.