77 FDA recalls mention Benzalkonium. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Benzalkonium.
Reason CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Reason CGMP Deviations
Reason Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus…
Reason Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Reason Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Reason CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.
Reason CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.
Reason Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Reason CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or soft tissues.
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason Microbial Contamination of Non-Sterile Products; lot tested positive for Bulkholderia multivorans
Reason CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be…
Reason CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be…
Reason Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia…
Reason Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia…
Reason Microbial contamination of non-sterile products: positive microbial contamination in product.
Reason Lack of Assurance of Sterility
Reason CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Reason Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product
Reason Labeling: Label mix-up - the label on the product may not match the formula in the bottle.
Reason CGMP Deviations: Product was released to market prior to microbiological testing.
Reason CGMP Deviations: Product was released to market prior to microbiological testing.
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