FDA-Drug2025-10-08Class II
Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.
Hazard
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Sold states
Distributed Nationwide in the USA
Affected count
600 30-count bottles
Manufactured in
73 Route 31 N, N/A, Pennington, NJ, United States
Products
Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0002-2026Want us to check the next one for you?
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