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.
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According to the FDA, a Class II risk is a situation “in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.”
The 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 hydrochloride to 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:
Check the code information and lot numbers here.
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.
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.
Video
According to the FDA, a Class II risk is a situation “in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.”
The 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 recall affects more than 580,000 prazosin hydrochloride capsules. Three dosage variants of the drug are affected:
- 1 mg capsules: 181,659 bottles
- 2 mg capsules: 291,512 bottles
- 5 mg capsules: 107,673 bottles
Check the code information and lot numbers here.
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.
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