Recall Enforment Report D-0241-2022

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Bayer Healthcare Pharmaceuticals Inc., originally initiated on 10-01-2021 for the product Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0 41100 40788 7, NDC 11523-4327-1; (b) 3-pack UPC 0 41100 58593 6; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain The product was recalled due to cgmp deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0241-202210-01-202111-24-2021Class II1,801,332 cansLotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0 41100 40788 7, NDC 11523-4327-1; (b) 3-pack UPC 0 41100 58593 6; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of SpaincGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.Terminated
D-0239-202210-01-202111-24-2021Class II77,076 cansLOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 59036 7, NDC 11523-0010-1.cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.Terminated
D-0250-202210-01-202111-24-2021Class I738,432 cansTinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105Chemical Contamination: presence of benzeneTerminated
D-0248-202210-01-202111-24-2021Class I3,816,468 cansLOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-0544-2 UPC 3 11017 41025 7Chemical Contamination: presence of benzeneTerminated
D-0236-202210-01-202111-24-2021Class II2,817,468 cansLOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.Terminated
D-0246-202210-01-202111-24-2021Class I2,817,468 cansLOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3Chemical Contamination: presence of benzeneTerminated
D-0254-202210-01-202111-24-2021Class II579,456 unitsLOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 58720 6, NDC 11523-0010-2; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, Packaged with LOTRIMIN ULTRA (butenafine hydrochloride 1%) cream, UPC 0 11017 40823 9, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Japan, ECOM PK UPC 00041100590756 NDC 11523-0010-2cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.Terminated
D-0249-202210-01-202111-24-2021Class I579,456 cansLotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 58720 6, NDC 11523-0010-2.Chemical Contamination: presence of benzeneTerminated
D-0240-202210-01-202111-24-2021Class II579,456 cansLOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, packaged as (a) single pack, UPC 0 41100 58720 6, NDC 11523-0010-2; (b) 3-pack, UPC 0 41100 58961 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland,cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.Terminated
D-0252-202210-01-202111-24-2021Class I592,416 cansTinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland 20066104 UPC 3 11017 41007 3, NDC 11523-0072-5Chemical Contamination: presence of benzeneTerminated
D-0244-202210-01-202111-24-2021Class II592,416 cansTinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Ireland 86951967, UPC 3 11017 41007 3, NDC 11523-0072-5cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.Terminated
D-0237-202210-01-202111-24-2021Class II4,546,152 cansLOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.Terminated
D-0243-202210-01-202111-24-2021Class II4,990,860 cansTinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, (c) Product of Ireland 87022897, with an instant redeemable coupon (IRC) tag attached to the can; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3 Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3.cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.Terminated
D-0247-202210-01-202111-24-2021Class I4,546,152 cansLOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8Chemical Contamination: presence of benzeneTerminated
D-0251-202210-01-202111-24-2021Class I4,990,860 cansTinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3.Chemical Contamination: presence of benzeneTerminated
D-0253-202210-01-202111-24-2021Class I2,841,012 cansTinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 86940418; (b)Product of Finland 20006106; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.Chemical Contamination: presence of benzeneTerminated
D-0242-202210-01-202111-24-2021Class II738,432 cansTinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4, NDC 11523-4162-1, Product of Finland 86568411; (b) UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.Terminated
D-0238-202210-01-202111-24-2021Class II3,816,468 cansLOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC 11523-0544-2 UPC 3 11017 41025 7; (b) 3 pack, NDC 11523-0544-2, UPC 0 41100 58594 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, ,cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.Terminated
D-0245-202210-01-202111-24-2021Class II2,841,012 cansTinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (b)Product of Finland 20006106, (c) Product of Ireland with Instant redeemable coupon ( IRC); Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
11523-0010Lotrimin Daily Prevention Deo TolnaftateAerosol, PowderTopicalBayer Healthcare Llc.Human Otc Drug
11523-0072Tinactin TolnaftateAerosol, PowderTopicalBayer Healthcare LlcHuman Otc Drug
11523-0165Tinactin TolnaftateAerosol, SprayTopicalBayer Healthcare LlcHuman Otc Drug
11523-0544Lotrimin AntifungalMiconazole NitrateAerosol, PowderTopicalBayer Healthcare Llc.Human Otc Drug
11523-0777Tinactin TolnaftateAerosol, PowderTopicalBayer Healthcare Llc.Human Otc Drug
11523-1272Lotrimin AntifungalMiconazole NitrateAerosol, PowderTopicalBayer Healthcare Llc.Human Otc Drug
11523-4140Lotrimin AntifungalMiconazole NitrateAerosol, PowderTopicalBayer Healthcare Llc.Human Otc Drug
11523-4162Tinactin AntifungalTolnaftateAerosol, PowderTopicalBayer Healthcare Llc.Human Otc Drug
11523-4327Lotrimin Af AntifungalMiconazole NitrateSprayTopicalBayer Healthcare Llc.Human Otc Drug