AvKARE is voluntarily recalling 1,266 bottles of Silodosin (8mg) capsules, a prescription medication used to treat symptoms of an enlarged prostate. Testing revealed that the drug was subpotent, meaning it contained less than the required amount of active ingredient (94.9% vs the required minimum of 95.0%) and an impurity level slightly above specifications. The recall affects 90-count bottles manufactured by Amneal Pharmaceuticals of NY for AvKARE.
Because this medication is subpotent, it may not be fully effective in treating urinary symptoms associated with an enlarged prostate. There is also a small increase in a specific impurity, which could potentially affect the quality and safety of the medication over time.
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Manufactured for AvKare by Amneal Pharmaceuticals of NY, 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.
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Sources: FDA iRES · Raw API Response
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