Over half a million bottles of prazosin hydrochloride, a blood pressure medication, have been voluntarily recalled by Teva Pharmaceuticals USA due to the presence of a potential cancer-causing chemical exceeding safe limits. The FDA classified this as a Class II risk, meaning adverse health consequences are temporary or medically reversible, with serious risks being remote.More than half a million bottles of prazosin hydrochloride, a blood pressure medication, have been recalled after the discovery of a potential cancer-causing chemical, the US Food and Drug Administration (FDA) has announced.On 7 October, Teva Pharmaceuticals USA, headquartered in Parsippany, New Jersey, issued a voluntary recall, which the FDA classified as a Class II risk on 24 October.According to the FDA, a Class II risk is a situation “in which use of or exposure to a violative product maycause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.”Image credits: Getty ImagesThe recall was initiated after test results showed that the levels of the N-nitroso Prazosin impurity C in the specified lots exceeded the safe limit set under the Carcinogenic Potency Categorization Approach (CPCA).Exposure to these carcinogenic chemicals may lead to serious health risks, the FDA reported.What is prazosin hydrochloride used for?The FDA approves prazosin hydrochlorideto treat high blood pressure. The drug works by relaxing blood vessels to improve blood flow and reduce pressure. In addition to its approved use, doctors often prescribe it off-label for post-traumatic stress disorder (PTSD) to help manage symptoms such as nightmares and sleep disturbances.The recall affects more than 580,000 prazosin hydrochloride capsules. Three dosage variants of the drug are affected:1 mg capsules: 181,659 bottles2 mg capsules: 291,512 bottles5 mg capsules: 107,673 bottlesAccording to the FDA, the bottles may contain anywhere from 100 to 1,000 capsules.Check thecode information and lot numbershere.What should you do with the recalled medication?As of now, neither Teva Pharmaceuticals nor the FDA has issued detailed guidance for consumers who may have purchased the affected medication. However, health resource platform GoodRx advises anyone taking prazosin hydrochloride to check the lot number printed on their medication bottle. If the lot matches those listed in the recall, patients should contact their pharmacist or healthcare provider for further advice and dispose of the recalled medication.Note: The information provided in this article is for educational purposes only and is not intended as medical advice. Always consult a healthcare professional before starting any new medication or treatment.
Teva Pharmaceuticals Recalls Over 580,000 Bottles of Prazosin Hydrochloride Due to Cancer-Causing Chemical
Times of India•
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Publisher: Times of India
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