Reported Nov 24, 2021 · Terminated

Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (b)Product…

Bayer Healthcare Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bayer Healthcare Pharmaceuticals Inc. · 100 Bayer Blvd · Whippany, NJ · 07981-1544

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 byBayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2

Lot codes and dates: 14 of 14 products
Products covered by this recall
# Product as published
1 Lot # (a) CV015YT, EXP 10/31/2021
2 CV01AE7, EXP 2/28/2022
3 CV01CY2, EXP 4/30/2022'
4 CV01E6P, EXP 8/31/2022
5 TN00085, TN001EK, EXP 10/31/2022
6 TN001ZV, TN00274, EXP 12/31/2022
7 TN003CU, EXP 1/31/2023
8 TN003CV, EXP 3/31/2023
9 TN0047H, EXP 4/30/2023
10 TN0047R, EXP 5/31/2023
11 (b)TN0067B, EXP 9/30/2022
12 TN006AT, EXP 12/31/2022
13 TN006TA, EXP 2/28/2023
14 (c) CV01E6PV, CV01E6PD, CV01E6PC, CV01E6PBV, CV01E6PAV, EXP 8/31/2022
Amount recalled: 2,841,012 cans

The agency filed one notice per product. You are reading one of them; the other 18 are below.

6 more are in the archive.

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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#	Product as published
1	Lot # (a) CV015YT, EXP 10/31/2021
2	CV01AE7, EXP 2/28/2022
3	CV01CY2, EXP 4/30/2022'
4	CV01E6P, EXP 8/31/2022
5	TN00085, TN001EK, EXP 10/31/2022
6	TN001ZV, TN00274, EXP 12/31/2022
7	TN003CU, EXP 1/31/2023
8	TN003CV, EXP 3/31/2023
9	TN0047H, EXP 4/30/2023
10	TN0047R, EXP 5/31/2023
11	(b)TN0067B, EXP 9/30/2022
12	TN006AT, EXP 12/31/2022
13	TN006TA, EXP 2/28/2023
14	(c) CV01E6PV, CV01E6PD, CV01E6PC, CV01E6PBV, CV01E6PAV, EXP 8/31/2022