Bayer Healthcare Pharmaceuticals Inc.
Bayer Healthcare Pharmaceuticals Inc. appears in FDA public data with 30 recalls — including 10 Class I (most serious) —, 0 510(k) clearances, 10 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0145-2024, Class I) was initiated on November 6, 2023.
Summary
- Total Recalls
- 30 (10 Class I)
- 510(k) Clearances
- 0
- Inspections
- 10
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0145-2024 | Class I | VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer Heal | November 6, 2023 |
| D-0239-2022 | Class II | LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can, Dist b | October 1, 2021 |
| D-0238-2022 | Class II | LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single | October 1, 2021 |
| D-0245-2022 | Class II | Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 8 | October 1, 2021 |
| D-0243-2022 | Class II | Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 200 | October 1, 2021 |
| D-0240-2022 | Class II | LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, packa | October 1, 2021 |
| D-0254-2022 | Class II | LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 | October 1, 2021 |
| D-0242-2022 | Class II | Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017 | October 1, 2021 |
| D-0244-2022 | Class II | Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare L | October 1, 2021 |
| D-0251-2022 | Class I | Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20 | October 1, 2021 |
| D-0249-2022 | Class I | Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ) can, Dist | October 1, 2021 |
| D-0237-2022 | Class II | LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer | October 1, 2021 |
| D-0236-2022 | Class II | LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer | October 1, 2021 |
| D-0246-2022 | Class I | LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer | October 1, 2021 |
| D-0248-2022 | Class I | LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthc | October 1, 2021 |
| D-0252-2022 | Class I | Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare L | October 1, 2021 |
| D-0250-2022 | Class I | Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare | October 1, 2021 |
| D-0241-2022 | Class II | Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single p | October 1, 2021 |
| D-0247-2022 | Class I | LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Ba | October 1, 2021 |
| D-0253-2022 | Class I | Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 8 | October 1, 2021 |