Biocon Pharma Inc. is recalling 3,665 bottles of Posaconazole Delayed-Release Tablets (100 mg) because the medication failed to meet quality standards for impurities and degradation. This means the drug is breaking down faster than expected during its shelf life. The recall affects 60-count prescription bottles sold nationwide to pharmacies and hospitals.
The drug failed 'Out Of Specification' testing for degradation, which could result in a patient receiving an ineffective dose of the medication or being exposed to higher levels of impurity byproducts. No incidents or injuries have been reported to date.
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Manufactured by: Biocon Pharma Limited, Bengaluru, India; Manufactured for: Biocon Pharma Inc., Iselin, NJ.
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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