17 FDA recalls mention Hydrogen. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Hydrogen.
Reason Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol
Reason CGMP Deviations: products may not conform to the labeled specifications.
Reason cGMP deviation: Product held outside of appropriate temperature storage conditions.
Reason cGMP deviation: Product held outside of appropriate temperature storage conditions.
Reason Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.
Reason Labeling: Label Mix-Up-The primary label on the front of the bottles have Hydrogen Peroxide affixed to the front and back of the containers. However…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Cross Contamination: Presence of IPA in finished product.
Reason cGMP Deviations
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility…
Reason The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free…
Reason Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility…
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 because…
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