Appco Pharma LLC is recalling 175,061 bottles of Prazosin Hydrochloride Capsules (1mg, 2mg, and 5mg), a medication used to treat high blood pressure, because they may contain an impurity called N-nitroso-prazosin (NNP) above acceptable limits. The recalled products were manufactured for Biocon Pharma Inc. and distributed nationwide in the United States. While no injuries have been reported, nitrosamines are substances that may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.
The medication contains N-nitroso-prazosin, a nitrosamine drug substance-related impurity, at levels that exceed the daily acceptable intake limit. Long-term exposure to these impurities above safety levels is associated with a potential increased risk of cancer.
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Manufactured for Biocon Pharma Inc. by Appco Pharma LLC.
Manufactured for Biocon Pharma Inc. by Appco Pharma LLC.
Manufactured for Biocon Pharma Inc. by Appco Pharma LLC.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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