15 FDA recalls mention Phytonadione. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Phytonadione.
Reason Failed Stability Specifications: Observed OOS results: eg results for colour index
Reason Lack of sterility assurance
Reason Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Reason Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
Reason Failed Impurities/Degradation Specifications
Reason Failed Impurities/Degradation Specifications
Reason Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Reason Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Reason Defective Container: Recall is due to breaking and shattering of ampules upon opening
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Labeling: Label Mixup; PHYTONADIONE Tablet, 5 mg may be potentially mislabeled as medroxyPROGESTERone ACETATE, Tablet, 10 mg, NDC 59762374202…
Reason Labeling: Label Mixup; PHYTONADIONE Tablet, 5 mg may be potentially mislabeled as medroxyPROGESTERone ACETATE, Tablet, 10 mg, NDC 59762374202…
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA…
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