A pharmaceutical company has issued a voluntary recall for more than a half-million bottles of blood pressure medication after tests showed the capsules had high levels of potentially cancer-causing chemicals.
An enforcement report from the Food and Drug Administration said New Jersey-based Teva Pharmaceuticals USA Inc. recalled 580,844 bottles of Prazosin Hydrochloride capsules that were distributed nationwide.
According to the report, the recall was initiated because tests for the capsules, which came in doses of 1, 2 and 5 mg, showed they had “above acceptable intake limits” for N-nitroso Prazosin impurity C, a cancer-linked chemical compound.
The recall was initiated Oct. 7, the report said. Oct. 24, the recall was classified as a “Class II,” which means the product “may cause temporary or medically reversible adverse health consequences,” or where the probability of serious adverse health consequences is remote.
According to the Health Hazard Assessment by Teva USA, the overall harm in the patient population is considered to be medium, the California Board of Pharmacy said in a memo.
In total, 55 lots of the pills were recalled. A full list of impacted lot codes can be found here.
In a statement sent to NBC Chicago, Teva confirmed its voluntary, nationwide recall of Prazosin Hydrocholoride Capsules USP in 1mg, 2mg and 5 mg.
Teva went on to say that it had not receive any “relevant complaints” related to the product.
“Prazosin is indicated for the treatment of hypertension, to lower blood pressure, and there are many alternative treatments available to patients,” the statement said. “Teva prioritizes patient safety and product quality at every stage of a medicine’s lifecycle.”
Those who do take the medication are advised to contact their pharmacy to determine what to do with the remaining quantities, Teva said. Teva also said it sent recall letters to its customers with instructions for returning recalled product.
“In addition, consumers with questions or concerns should also contact the health care provider who prescribed the medication,” Teva said.
The drug, more commonly referred to as Prazosin, is a type of alpha-blocker used to treat hypertension, according to the Cleveland Clinic. The drug is sometimes sold under the name of Minipress, the clinic said.
Last month, Lipitor, a widely used cholesterol medication, was also recently recalled for “failed dissolution specifications,” which suggests the drugs did not properly dissolve at a standard rate and could lead to a reduction in the drug’s effectiveness.