FDA Recalls 580,000 Bottles of Blood Pressure Drug Over Cancer Risk
The Federal Drug Administration (FDA) has announced the recall of over 580,000 bottles of a blood pressure medication due to concerns about cancer risk. Teva Pharmaceuticals USA, based in New Jersey, along with Amerisource Health Services, issued these recalls for various strengths of prazosin capsules earlier this month.
Details of the Recall
The recalled medication, prazosin hydrochloride, is available in three dosages: 1 mg, 2 mg, and 5 mg. This drug is primarily used to relax blood vessels, aiding blood flow. Additionally, it may be prescribed for sleep disturbances, particularly those related to post-traumatic stress disorder (PTSD).
Reasons for Recall
The FDA has assigned a Class II risk classification to the affected lots. This classification indicates that the medication may contain nitrosamine impurities, which have been identified as potentially carcinogenic. These harmful chemicals can develop during the manufacturing or storage processes of the drug.
Impacted Products
- Drug Name: Prazosin Hydrochloride
- Strengths: 1 mg, 2 mg, 5 mg
- Number of Bottles Recalled: Over 580,000
- Manufacturers: Teva Pharmaceuticals USA and Amerisource Health Services
- Risk Classification: Class II
FDA Actions
The FDA’s recall notices highlight the potential risks associated with the medication. Teva Pharmaceuticals did not respond immediately to inquiries regarding the recall. Patients using this medication are advised to consult with their healthcare providers regarding alternatives and further actions.
This recall emphasizes the importance of monitoring pharmaceutical products for safety and efficacy. Consumers are encouraged to remain informed about their medications and report any adverse effects to their healthcare providers.
