Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole…
Reason CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
458 FDA recalls mention Alcohol. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Alcohol.
Reason CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Reason Lack of Assurance of Sterility
Reason Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Reason Lack of Assurance of Sterlity
Reason Subpotent Drug
Reason cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand…
Reason cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand…
Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Reason Cross Contamination with Other Products.
Reason Cross Contamination with Other Products.
Reason cGMP Deviations
Reason Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Reason Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Reason Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Reason Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Reason Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Reason Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Reason Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
Reason Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Reason cGMP deviations and lack of assurance of sterility.
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