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Bayer HealthCare Pharmaceuticals, Inc.

FDA Regulatory Profile

Summary

Total Recalls
30 (10 Class I)
510(k) Clearances
0
Inspections
9
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0145-2024Class IVITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealNovember 6, 2023
D-0240-2022Class IILOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, packaOctober 1, 2021
D-0251-2022Class ITinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20October 1, 2021
D-0250-2022Class ITinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare October 1, 2021
D-0241-2022Class IILotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pOctober 1, 2021
D-0247-2022Class ILOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: BaOctober 1, 2021
D-0237-2022Class IILOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer October 1, 2021
D-0253-2022Class ITinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 8October 1, 2021
D-0238-2022Class IILOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single October 1, 2021
D-0244-2022Class IITinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LOctober 1, 2021
D-0254-2022Class IILOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0October 1, 2021
D-0249-2022Class ILotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ) can, Dist October 1, 2021
D-0252-2022Class ITinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LOctober 1, 2021
D-0236-2022Class IILOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer October 1, 2021
D-0246-2022Class ILOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: BayerOctober 1, 2021
D-0248-2022Class ILOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer HealthcOctober 1, 2021
D-0239-2022Class IILOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can, Dist bOctober 1, 2021
D-0245-2022Class IITinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 8October 1, 2021
D-0243-2022Class IITinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 200October 1, 2021
D-0242-2022Class IITinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017October 1, 2021