Hetero USA Inc. has voluntarily recalled 5,664 bottles of Entecavir (0.5 mg) tablets, a prescription medication used to treat chronic hepatitis B. This recall was initiated because routine stability testing at the three-month mark identified a single unknown impurity that exceeded the allowed safety limit. While the specific impurity is unknown, the levels measured 0.33%, which is higher than the established safety limit of 0.20%. Consumers should check their prescription bottles to see if they are part of the affected lot (ENT17008) distributed in New Jersey.
The presence of an unknown impurity above the established safety limit means the medication does not meet quality standards, which could potentially lead to unexpected side effects or reduced effectiveness of the treatment.
Healthcare consultation and refund
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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