6 FDA recalls mention Entecavir. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Entecavir.
Reason Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
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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