The Food and Drug Administration confirmed in several notices that a recall of a type of high blood pressure medication has been expanded due to the presence of a potentially carcinogenic substance.
In three noticesissued this week, the FDA confirmed that 7,198 cartons of prazosin hydrochloride are being recalled nationwide by Ohio-based Amerisource Health Services and classified the recall as Class II.
N-nitroso prazosin, a nitrosamine found in the medication, is above the FDA’s acceptable limits, according to the FDA. Nitrosamines are a type of organic compound that is a potential human carcinogen that can form in food or other substances.
A Class II recall is considered by the FDA to be a serious but less severe product safety recall for a product that may cause temporary or medically reversible adverse health consequences or if there is a remote chance of a serious adverse health consequence associated with the item.
Latest Drugs Under Recall
The three items are:
- Prazosin Hydrochloride capsules USP in 1-milligram doses in 100-capsule (10×10) cartons, which are distributed by American Health Packaging. It has a Carton NDC of 68084-996-01, and it has individual unit doses of NDC 68084-996-11.
- Prazosin Hydrochloride capsules USP in 2-milligram doses in 100-capsule (10×10) cartons, which are distributed by American Health Packaging. It has a Carton NDC of 68084-997-01, and it has individual unit doses of NDC 68084-997-11.
- Prazosin Hydrochloride capsules USP in 5-milligram doses in 20-capsule (5×4) cartons, which are distributed by American Health Packaging. It has a Carton NDC of 60687-572-32, and it has individual unit doses of NDC 60687-572-33.
The FDA did not include any other information about the recalled items, including whether people should continue taking them. In numerous previous recalls for products that contain elevated nitrosamine levels, the FDA has generally advised people to continue taking the prescription medication.
Hellbound and Down 