Recall Enforment Report D-0241-2022
- NDC List
- Drug Recall Enforcement Reports
- Recall Enforcement Report: 88677
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-0241-2022 | 10-01-2021 | 11-24-2021 | Class II | 1,801,332 cans | 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 | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Terminated |
D-0239-2022 | 10-01-2021 | 11-24-2021 | Class II | 77,076 cans | LOTRIMIN 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-0250-2022 | 10-01-2021 | 11-24-2021 | Class I | 738,432 cans | Tinactin (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 20006105 | Chemical Contamination: presence of benzene | Terminated |
D-0248-2022 | 10-01-2021 | 11-24-2021 | Class I | 3,816,468 cans | LOTRIMIN 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 7 | Chemical Contamination: presence of benzene | Terminated |
D-0236-2022 | 10-01-2021 | 11-24-2021 | Class II | 2,817,468 cans | LOTRIMIN 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 3 | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Terminated |
D-0246-2022 | 10-01-2021 | 11-24-2021 | Class I | 2,817,468 cans | LOTRIMIN 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 3 | Chemical Contamination: presence of benzene | Terminated |
D-0254-2022 | 10-01-2021 | 11-24-2021 | Class II | 579,456 units | LOTRIMIN 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 11523-0010-2 | cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene. | Terminated |
D-0249-2022 | 10-01-2021 | 11-24-2021 | Class I | 579,456 cans | Lotrimin 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 benzene | Terminated |
D-0240-2022 | 10-01-2021 | 11-24-2021 | Class II | 579,456 cans | LOTRIMIN 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-0252-2022 | 10-01-2021 | 11-24-2021 | Class I | 592,416 cans | Tinactin (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 11523-0072-5 | Chemical Contamination: presence of benzene | Terminated |
D-0244-2022 | 10-01-2021 | 11-24-2021 | Class II | 592,416 cans | Tinactin (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 11523-0072-5 | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Terminated |
D-0237-2022 | 10-01-2021 | 11-24-2021 | Class II | 4,546,152 cans | LOTRIMIN 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 8 | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Terminated |
D-0243-2022 | 10-01-2021 | 11-24-2021 | Class II | 4,990,860 cans | Tinactin (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-0247-2022 | 10-01-2021 | 11-24-2021 | Class I | 4,546,152 cans | LOTRIMIN 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 8 | Chemical Contamination: presence of benzene | Terminated |
D-0251-2022 | 10-01-2021 | 11-24-2021 | Class I | 4,990,860 cans | 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. | Chemical Contamination: presence of benzene | Terminated |
D-0253-2022 | 10-01-2021 | 11-24-2021 | Class I | 2,841,012 cans | Tinactin (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 benzene | Terminated |
D-0242-2022 | 10-01-2021 | 11-24-2021 | Class II | 738,432 cans | Tinactin (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 07981 | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Terminated |
D-0238-2022 | 10-01-2021 | 11-24-2021 | Class II | 3,816,468 cans | LOTRIMIN 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-0245-2022 | 10-01-2021 | 11-24-2021 | Class II | 2,841,012 cans | Tinactin (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 |
---|---|---|---|---|---|---|
11523-0010 | Lotrimin Daily Prevention Deo | Tolnaftate | Aerosol, Powder | Topical | Bayer Healthcare Llc. | Human Otc Drug |
11523-0072 | Tinactin | Tolnaftate | Aerosol, Powder | Topical | Bayer Healthcare Llc | Human Otc Drug |
11523-0165 | Tinactin | Tolnaftate | Aerosol, Spray | Topical | Bayer Healthcare Llc | Human Otc Drug |
11523-0544 | Lotrimin Antifungal | Miconazole Nitrate | Aerosol, Powder | Topical | Bayer Healthcare Llc. | Human Otc Drug |
11523-0777 | Tinactin | Tolnaftate | Aerosol, Powder | Topical | Bayer Healthcare Llc. | Human Otc Drug |
11523-1272 | Lotrimin Antifungal | Miconazole Nitrate | Aerosol, Powder | Topical | Bayer Healthcare Llc. | Human Otc Drug |
11523-4140 | Lotrimin Antifungal | Miconazole Nitrate | Aerosol, Powder | Topical | Bayer Healthcare Llc. | Human Otc Drug |
11523-4162 | Tinactin Antifungal | Tolnaftate | Aerosol, Powder | Topical | Bayer Healthcare Llc. | Human Otc Drug |
11523-4327 | Lotrimin Af Antifungal | Miconazole Nitrate | Spray | Topical | Bayer Healthcare Llc. | Human Otc Drug |
Recall Enforcement Report D-0241-2022
Field Name | Field Value |
---|---|
Event ID | 88677 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
Recall Number | D-0241-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
Distribution Pattern | Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
Product Description | 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 |
Reason For Recall | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. What is the Reason for Recall? Information describing how the product is defective. |
Product Quantity | 1,801,332 cans Product Quantity The amount of product subject to recall. |
Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
Report Date | 11-24-2021 |
Recall Initiation Date | 10-01-2021 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
Termination Date | 06-26-2023 What is the Date Terminated? The date that FDA terminated the recall. |
Initial Firm Notification | Press Release Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
Product Type | Drugs |
Recalling Firm | Bayer Healthcare Pharmaceuticals Inc. |
Code Info | Lot # (a) TN000TR, EXP 10/31/2021; TN0011B, EXP 11/30/2021; TN003CC, TN003CD, EXP 02/28/2022; TN0040B, EXP 05/31/2022; TN0041U, EXP 06/30/2022; TN004BK, EXP 08/31/2022; TN005P3, EXP 10/31/2022; TN006AP, TN006MC, EXP 01/31/2023; TN006TB, EXP 04/30/2023; (b) TN000TR, EXP 10/31/2021; TN0011B, TN0011BA, EXP 11/30/2021; TN003CD, TN003CDA, TN003CDB,EXP 02/28/2022; TN0040BA, TN0040BV, EXP 05/31/2022; TN0041U,EXP 06/30/2022; TN004BK, EXP 08/31/2022; TN006MC, EXP 01/31/2023; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
Recalled NDC Packages | 11523-4327-1 |
Status | Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard. |
Recall Enforcement Report D-0239-2022
Recall Enforcement Report D-0250-2022
Recall Enforcement Report D-0248-2022
Recall Enforcement Report D-0236-2022
Recall Enforcement Report D-0246-2022
Recall Enforcement Report D-0254-2022
Field Name | Field Value |
---|---|
Event ID | 88677 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
Recall Number | D-0254-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
Distribution Pattern | Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
Product Description | LOTRIMIN 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 11523-0010-2 |
Reason For Recall | cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene. What is the Reason for Recall? Information describing how the product is defective. |
Product Quantity | 579,456 units Product Quantity The amount of product subject to recall. |
Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
Report Date | 11-24-2021 |
Recall Initiation Date | 10-01-2021 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
Termination Date | 06-26-2023 What is the Date Terminated? The date that FDA terminated the recall. |
Initial Firm Notification | Press Release Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
Product Type | Drugs |
Recalling Firm | Bayer Healthcare Pharmaceuticals Inc. |
Code Info | Lot # NAA8997, EXP 01/31/2022; NAA8EK8, EXP 02/28/2022; NAA9E18, NAA9LFP, NAA9T53, NAA5RW, EXP 08/31/2022; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
Recalled NDC Packages | 11523-0010-1; 11523-0010-2; 0004110059 |
Status | Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard. |
Recall Enforcement Report D-0249-2022
Recall Enforcement Report D-0240-2022
Field Name | Field Value |
---|---|
Event ID | 88677 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
Recall Number | D-0240-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
Distribution Pattern | Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
Product Description | LOTRIMIN 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, |
Reason For Recall | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. What is the Reason for Recall? Information describing how the product is defective. |
Product Quantity | 579,456 cans Product Quantity The amount of product subject to recall. |
Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
Report Date | 11-24-2021 |
Recall Initiation Date | 10-01-2021 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
Termination Date | 06-26-2023 What is the Date Terminated? The date that FDA terminated the recall. |
Initial Firm Notification | Press Release Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
Product Type | Drugs |
Recalling Firm | Bayer Healthcare Pharmaceuticals Inc. |
Code Info | Lot # (a)TN0023C, EXP 1/31/2022; TN003C7, EXP 4/30/2022; TN00570, EXP 7/31/2022; TN0056Z, TN005KJ, EXP 8/31/2022; (b)TN0023C, EXP 01/31/2022; TN003C7, EXP 04/30/2022; TN0023DV, TN0023DAV, TN0023DBV, TN0023DC, EXP 02/28/2022; TN005KJ, TN005KJA, TN005KJB, EXP 08/31/2022; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
Recalled NDC Packages | 11523-0010-1; 11523-0010-2 |
Status | Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard. |
Recall Enforcement Report D-0252-2022
Recall Enforcement Report D-0244-2022
Recall Enforcement Report D-0237-2022
Recall Enforcement Report D-0243-2022
Field Name | Field Value |
---|---|
Event ID | 88677 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
Recall Number | D-0243-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
Distribution Pattern | Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
Product Description | Tinactin (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. |
Reason For Recall | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. What is the Reason for Recall? Information describing how the product is defective. |
Product Quantity | 4,990,860 cans Product Quantity The amount of product subject to recall. |
Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
Report Date | 11-24-2021 |
Recall Initiation Date | 10-01-2021 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
Termination Date | 06-26-2023 What is the Date Terminated? The date that FDA terminated the recall. |
Initial Firm Notification | Press Release Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
Product Type | Drugs |
Recalling Firm | Bayer Healthcare Pharmaceuticals Inc. |
Code Info | Lot # (a)TN0060U, TN0060V, TN0060W, EXP 7/31/2022; TN0060X, TN0060Y, TN0060Z, TN006CJ, TN006CK, TN006CM, TN00610, EXP 9/30/2022; TN006YW, EXP 10/31/2022; TN006MY, TN006YX, TN006YY, EXP 12/31/2022; TN007EN, TN007EP, TN007ER, EXP 2/28/2023; (b)CV016TH, CV016TJ, CV017D8, CV017D7, EXP 10/31/2021; CV017XS, EXP 11/30/2021; CV01980, CV019DS, EXP 12/31/2021; CV01A72, CV01A73, CV01AE6, EXP 1/31/2022; CV01AUA, CV01B1E, EXP 2/28/2022; CV01BNE, EXP 3/31/2022; CV01BVU, EXP 3/31/2022; CV01CT6, CV01CY1, EXP 4/30/2022; CV01D2G, EXP 5/31/2022; CV01DRX, CV01DRY, CV01E2T, EXP 6/30/2022; CV01E2W, CV01E2X, EXP 7/31/2022; CV01E2U, EXP 7/31/2022; CV01E2V, EXP 8/31/2022; TN001V6, EXP 11/30/2022; TN00243, EXP 12/31/2022; TN0024B, TN0024C, TN0024D, TN0024E, TN003C6, EXP 1/31/2023; TN00408, TN00409, TN0047J, TN0047K, TN0040A, EXP 4/30/2022, (c) CV01DRX, CV01DRY, CV01E2T, EXP 6/30/2022 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
Recalled NDC Packages | 11523-0165-3 |
Status | Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard. |
Recall Enforcement Report D-0247-2022
Recall Enforcement Report D-0251-2022
Recall Enforcement Report D-0253-2022
Recall Enforcement Report D-0242-2022
Recall Enforcement Report D-0238-2022
Field Name | Field Value |
---|---|
Event ID | 88677 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
Recall Number | D-0238-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
Distribution Pattern | Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
Product Description | LOTRIMIN 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, , |
Reason For Recall | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. What is the Reason for Recall? Information describing how the product is defective. |
Product Quantity | 3,816,468 cans Product Quantity The amount of product subject to recall. |
Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
Report Date | 11-24-2021 |
Recall Initiation Date | 10-01-2021 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
Termination Date | 06-26-2023 What is the Date Terminated? The date that FDA terminated the recall. |
Initial Firm Notification | Press Release Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
Product Type | Drugs |
Recalling Firm | Bayer Healthcare Pharmaceuticals Inc. |
Code Info | Lot # (a) CV017D9, EXP 10/31/2021; CV01940, EXP 11/30/2021; CV01CD9, EXP 4/30/2022; CV01D9T, CV01DZ3, EXP 6/30/2022; CV01EPP, EXP 7/31/2022; TN000TT, EXP 10/31/2022; TN003CG, EXP 1/31/2023; TN003CH, TN00407, EXP 3/31/2023; TN0041V, EXP 6/30/2023; TN0056W, EXP 7/31/2022; TN005P4, EXP 8/31/2022; TN006MJ, EXP 9/30/2022; (b) CV01940, CV01940A, EXP 11/30/2021; CV01AP2, EXP 02/28/2022; CV01D9T, CV01D9TA, CV01DZ3, EXP 06/30/2022; CV01EPP, EXP 07/31/2022; TN005P4, EXP 08/31/2022; TN000TT, TN000TTA, EXP 10/31/2022; TN003CG, EXP 01/31/2023; TN003CH, TN003CHA, TN00407, TN006TD, TN006TDB, TN00407A, EXP 03/31/2023; TN0041V, EXP 06/30/2023 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
Recalled NDC Packages | 11523-0544-2 |
Status | Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard. |
Recall Enforcement Report D-0245-2022
Field Name | Field Value |
---|---|
Event ID | 88677 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
Recall Number | D-0245-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
Distribution Pattern | Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
Product Description | Tinactin (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. |
Reason For Recall | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. What is the Reason for Recall? Information describing how the product is defective. |
Product Quantity | 2,841,012 cans Product Quantity The amount of product subject to recall. |
Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
Report Date | 11-24-2021 |
Recall Initiation Date | 10-01-2021 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
Termination Date | 06-26-2023 What is the Date Terminated? The date that FDA terminated the recall. |
Initial Firm Notification | Press Release Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
Product Type | Drugs |
Recalling Firm | Bayer Healthcare Pharmaceuticals Inc. |
Code Info | Lot # (a) CV015YT, EXP 10/31/2021; CV01AE7, EXP 2/28/2022; CV01CY2, EXP 4/30/2022'; CV01E6P, EXP 8/31/2022; TN00085, TN001EK, EXP 10/31/2022; TN001ZV, TN00274, EXP 12/31/2022; TN003CU, EXP 1/31/2023; TN003CV, EXP 3/31/2023; TN0047H, EXP 4/30/2023; TN0047R, EXP 5/31/2023; (b)TN0067B, EXP 9/30/2022; TN006AT, EXP 12/31/2022; TN006TA, EXP 2/28/2023; (c) CV01E6PV, CV01E6PD, CV01E6PC, CV01E6PBV, CV01E6PAV, EXP 8/31/2022 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
Recalled NDC Packages | 11523-0777-2 |
Status | Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard. |