Zydus Pharmaceuticals USA Inc. recalls Entecavir tablets after FDA enforcement reports impurity/degradation failures. The recall affects 4,440 bottles distributed nationwide. Providers and patients should stop use and seek guidance from a healthcare professional.
Failed Impurity/Degradation Specifications
Consumers and healthcare providers should stop using this product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance. Notification method: N/A
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Entecavir tablets are an antiviral used to treat hepatitis B. They are prescription-only and require medical supervision.
Impurity or degradation can affect drug purity and potency, potentially compromising treatment efficacy.
This recall is not part of a broader industry pattern at this time.
Consumers and healthcare providers should stop use and consult a clinician for alternatives; no injuries reported in the data.
NDC on bottle, packaging insert, and the FDA recall page linked in notices
Refunds/replacements typically processed within several weeks after confirmation
Keep bottle packaging, recall notice, and correspondence with supplier for records
Product: Entecavir Tablets, USP 1 mg, 30 Tablets. Manufacturer: Zydus Lifesciences Ltd., Ahmedabad, India. Distributor: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 68382-921-06. Lot: E309377. Expiration: 11/30/2025. Quantity: 4,440 bottles. Sold nationwide in the U.S.
No specific incidents or injuries are reported in the provided data.
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