13 FDA recalls mention Selenium. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Selenium.
Reason CGMP Deviations: Stability data does not support expiry date.
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Reason Lack of Assurance of Sterility
Reason Lack of sterility assurance.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Reason Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility…
Reason Labeling: Label Mixup :SELENIUM, Tablet, 50 mcg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC…
Reason Non-Sterility; contract laboratory identified Staphylococcus warneri in the product
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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