Ent ecavir 0.5 mg tablets, distributed nationwide in the United States by Zydus Pharmaceuticals USA Inc., are recalled, affecting 912 bottles. The recall is due to an out-of-specification organic impurity detected in a batch, Class II. Healthcare providers and patients should stop using the product immediately and contact Zydus Pharmaceuticals USA for guidance.
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Consumers and healthcare providers should stop using this product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance. Notification method: Letter
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Entecavir is an antiviral used to treat chronic hepatitis B in adults and some pediatric patients. It lowers the amount of hepatitis B virus in the body and reduces liver damage.
The product failed impurity/degradation specifications. An individual organic impurity detected in the product could pose a health risk if consumed.
This recall is not described as part of a broader industry pattern in the provided information.
If contaminated, patients may experience adverse effects from impurity exposure. Consumers should stop use and consult a clinician. There could be disruption to treatment plans.
Identifiers appear on the bottle and outer packaging. The NDC is 68382-920-06. The lot is E409308 and the exp date is 12/31/2026.
Refunds or replacements are typically processed within 4-6 weeks after eligibility is confirmed.
Keep the recall notice, bottle labels, receipts, and any correspondence. Photograph the product and packaging for your records.
Product: Entecavir Tablets, USP, 0.5 mg, 30-count bottle. NDC: 68382-920-06. Manufacturer: Zydus Lifesciences Ltd., Ahmedabad, India. Distributor: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. Lot number: E409308. Expiration: 12/31/2026. Quantity: 912 bottles. Sold nationwide in the USA. Recall date: 2025-09-24.
No injuries or incidents have been reported.
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