This recall involves Diltiazem Hydrochloride Extended-Release Capsules (360 mg), a medication used to treat high blood pressure and chest pain, sold under the Sun Pharmaceutical Industries brand. Approximately 3,120 units are affected by this recall because the medication failed laboratory testing for both impurity levels and dissolution. These failures mean the drug may not break down or release correctly in the body, which could impact the effectiveness of the treatment.
The drug failed dissolution testing and contained an impurity (Deacetyl Diltiazem Hydrochloride) that exceeded specifications. If the medication does not dissolve properly, it may not provide the intended dose of medicine, potentially failing to control serious heart conditions or blood pressure.
You have 2 options:
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing.
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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