Major Blood Pressure Medication Recall; Drug May Contain Carcinogen
According to a company press release, Prinston Pharmaceuticals, based in New Jersey, has recalled one lot of Irbesartan and seven lots of Irbesartan HCTZ. The widely prescribed drugs are used to control high blood pressure and heart failure.
According to the FDA, the recall is the result of “the detection of trace amount of an unexpected impurity found in an active pharmaceutical ingredient (API)”, which is manufactured by Zhejiang Huahai Pharmaceuticals, a Chinese company. The FDA issued a warning letter to the company following an inspection last summer. A story from BioPharmaDive.com last October indicated the FDA had banned all drug imports from Zhejiang Huahai Pharmaceuticals on the heals of a contamination issue with another blood pressure drug, valsartan.
The Irbesartan container will bear one of the following:
- 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.
According to an article from The Atlanta Journal-Constitution:
The substance is N-nitrosodiethylamine, and the medications recalled were found to have above the acceptable daily intake levels released by the Food and Drug Administration. NDEA is an impurity, which can be found in certain foods, drinking water and in polluted air as well. It has been classified as a human carcinogen by the FDA. A previous recall involving the drug Valsartan occurred last summer. Valsartan was also found to contain NDEA
Irbesartan may be used in combination with amlodipine and hydrochlorothiazide to control high blood pressure, according to the FDA. If you are unsure if your prescription falls under the recall, you can contact the pharmacy that filled your prescription for information as well. The FDA further advised that patients should also talk to their doctor about alternative medications. But they also advise that patients continue using the medication until they get direction from their physician as stopping it could be a higher risk to their health than N-nitrosodiethylamine.
[Sources: Atlanta Journal-Constitution, FDA]