Nov 6, 2023 FDA drug enforcement
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Class I Reported terminated
Distribution: Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.
Official source for VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer H... Oct 1, 2021 FDA drug enforcement
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II Reported terminated
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Official source for LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bay... Oct 1, 2021 FDA drug enforcement
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II Reported terminated
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Official source for LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bay... Oct 1, 2021 FDA drug enforcement
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II Reported terminated
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Official source for LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a sing... Oct 1, 2021 FDA drug enforcement
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II Reported terminated
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Official source for LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can, Dis... Oct 1, 2021 FDA drug enforcement
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II Reported terminated
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Official source for LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, pa... Oct 1, 2021 FDA drug enforcement
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II Reported terminated
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Official source for Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single... Oct 1, 2021 FDA drug enforcement
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II Reported terminated
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Official source for Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11... Oct 1, 2021 FDA drug enforcement
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II Reported terminated
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Official source for Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland ... Oct 1, 2021 FDA drug enforcement
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II Reported terminated
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Official source for Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcar... Oct 1, 2021 FDA drug enforcement
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II Reported terminated
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Official source for Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland... Oct 1, 2021 FDA drug enforcement
Chemical Contamination: presence of benzene
Class I Reported terminated
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Official source for LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Ba... Oct 1, 2021 FDA drug enforcement
Chemical Contamination: presence of benzene
Class I Reported terminated
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Official source for LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4.6 OZ) can, Dist by:... Oct 1, 2021 FDA drug enforcement
Chemical Contamination: presence of benzene
Class I Reported terminated
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Official source for LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Heal... Oct 1, 2021 FDA drug enforcement
Chemical Contamination: presence of benzene
Class I Reported terminated
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Official source for Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ) can, Di... Oct 1, 2021 FDA drug enforcement
Chemical Contamination: presence of benzene
Class I Reported terminated
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Official source for Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthca... Oct 1, 2021 FDA drug enforcement
Chemical Contamination: presence of benzene
Class I Reported terminated
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Official source for Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland ... Oct 1, 2021 FDA drug enforcement
Chemical Contamination: presence of benzene
Class I Reported terminated
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Official source for Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcar... Oct 1, 2021 FDA drug enforcement
Chemical Contamination: presence of benzene
Class I Reported terminated
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Official source for Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland... Oct 1, 2021 FDA drug enforcement
cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II Reported terminated
Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Official source for LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UP...