Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
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.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Reason Failed Impurity/Degradation Specifications
Reason Failed Impurity/Degradation Specifications
Reason Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Reason Labeling: Label Mixup: ENTECAVIR, Tablet, 0.5 mg may be potentially mis-labeled as one of the following drugs: ARIPiprazole, Tablet, 2 mg, NDC…
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