FDARecalled Oct 8, 2025 · #D-0001-2026
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 683...
Hazard
Class II — temporary health risk
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Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity Classification: Class II Distribution: Distributed Nationwide in the USA
Product details
- Product
- Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
- Type
- Drugs
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Model numbers
- E409308
- UPCs
- —