The FDA is alerting patients of a recent recall of irbesartan, an angiotensin II receptor blocker (ARB) used to treat heart disease. Tests showed that the recalled lots, manufactured by SciGen Pharmaceuticals, contain a possible human carcinogen.
This is the second recall this year where a cancer-causing agent was found in an ARB heart medication. This past June, multiple manufacturers recalled valsartan products because of concerns over carcinogenic contaminants, spurring a widespread investigation by the FDA on all ARB drugs.
What is irbesartan for?
Irbesartan is an angiotensin II receptor blocker (ARB) used to treat high blood pressure and heart failure, and to slow the progression of kidney disease in diabetic patients.
Why were the products recalled?
The FDA recalled certain lots of irbesartan after they discovered that some products were contaminated with NDEA (N-nitrosodiethylamine), a human and animal carcinogen. Used to make rocket fuel, NDEA can be unintentionally introduced during the drug manufacturing process through certain chemical reactions.
Which products were recalled?
According to the FDA, this recall is only affecting about 1% of all irbesartan drug products available in the US. Aurobindo Pharmaceuticals supplied contaminated ingredients to manufacturer ScieGen Pharmaceuticals, and the final drug products were then distributed by Westminster Pharmaceuticals and Golden State Medical Supply.
Here’s information for the recalled products:
- NDC codes: 69367-119-01, 69367-119-03, 69367-120-01, 69367-120-03, 69367-121-01, 69367-121-03
- Lot numbers: B160002A, B160002B, B161005A, C161002A, B161005B, C161002B, B162008A, C162002A, B162008B, C162002B
Golden State Medical Supply batches:
- NDC codes: 60429-641-30, 60429-642-30, 60429-640-90, 60429-641-90, 60429-642-90
- Lot numbers: GS019526, GS020252, GS020958, GS019036, GS019073, GS021472, GS021530, GS022234, B160003, B160004, B161003, B161004, B161006, B161007, B161008, B161009, B161010, C161001, C161003, B162009, B162010, B162011, B162012, B162013, B162014, B162015, C162001
To find out whether your specific product has been recalled, look for the drug name and company name on the label of your prescription bottle. If that information is not on the bottle, contact the pharmacy that dispensed it to you.
I think have a recalled irbesartan product. What should I do?
If you believe you may be affected by this recall, examine your pill bottle and contact your pharmacy or physician, but do not stop taking your medication until you have an effective replacement.
If you have a recalled product, return it to your pharmacy. The pharmacy will send it back to the wholesaler and give you a new bottle of irbesartan that hasn’t been recalled. If you no longer feel comfortable taking this medication, even from a different manufacturer, please speak with your doctor to find out if a different blood pressure medication may work for you.
How can I contact my drug manufacturer?
If you have additional questions about this recall, contact the distributor listed on your irbesartan bottle. Westminster’s Regulatory Affairs department can be reached at 1-888-354-9939, and Golden State Medical Supply Incorporated can be reached at 1-800-284-8633, Ext. 215.
If you are unable to locate the distributor, you can also call ScieGen Pharmaceuticals Inc. at 1-855-724-3436.
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Always inspect your medications, including all parts of the packaging and devices. If you ever notice your medication doesn’t look or smell right, contact the manufacturer or ask your pharmacist for more information. Contact information for manufacturers of recalled irbesartan products are available above. Any adverse reactions or quality problems can also be reported to the FDA’s MedWatch Reporting Program as they can conduct further investigations.
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