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Bayer Healthcare Pharmaceuticals Inc. FDA Recalls

20 recalls on file across drugs, 9 of them Class I and 0 still open. This firm is not matched to a listed company.

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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare PharmaceuticaClass INov 6, 2023Microbial Contamination of Non-Sterile Products: microbial c
LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Class IOct 1, 2021Chemical Contamination: presence of benzene
Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ) can, Dist by: Bayer HealthcareClass IOct 1, 2021Chemical Contamination: presence of benzene
LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC 11523-0544-Class IIOct 1, 2021cGMP Deviations: manufactured at the same facility where oth
Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0 41100 407Class IIOct 1, 2021cGMP Deviations: manufactured at the same facility where oth
Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 86940418; (b)Product Class IOct 1, 2021Chemical Contamination: presence of benzene
Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 079Class IIOct 1, 2021cGMP Deviations: manufactured at the same facility where oth
LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare Class IIOct 1, 2021cGMP Deviations: manufactured at the same facility where oth
Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product Class IOct 1, 2021Chemical Contamination: presence of benzene
LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, WhiClass IOct 1, 2021Chemical Contamination: presence of benzene
LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, WhipClass IIOct 1, 2021cGMP Deviations: manufactured at the same facility where oth
LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 58720 6, NDC Class IIOct 1, 2021cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at
LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, WhipClass IIOct 1, 2021cGMP Deviations: manufactured at the same facility where oth
Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (b)Product Class IIOct 1, 2021cGMP Deviations: manufactured at the same facility where oth
LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NClass IOct 1, 2021Chemical Contamination: presence of benzene
LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, packaged as (a) single paClass IIOct 1, 2021cGMP Deviations: manufactured at the same facility where oth
Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07Class IOct 1, 2021Chemical Contamination: presence of benzene
Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 079Class IOct 1, 2021Chemical Contamination: presence of benzene
Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4, NDC 11523Class IIOct 1, 2021cGMP Deviations: manufactured at the same facility where oth
Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 20006101, (b) Product oClass IIOct 1, 2021cGMP Deviations: manufactured at the same facility where oth

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