Recalls / Class II
Class IID-0243-2022
Product
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.
- Brand name
- Tinactin
- Generic name
- Tolnaftate
- Active ingredient
- Tolnaftate
- Route
- Topical
- NDC
- 11523-0165
- FDA application
- M005
- Affected lot / 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
Why it was recalled
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Recalling firm
- Firm
- Bayer Healthcare Pharmaceuticals Inc.
- Manufacturer
- Bayer HealthCare LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 100 Bayer Blvd, N/A, Whippany, New Jersey 07981-1544
Distribution
- Quantity
- 4,990,860 cans
- Distribution pattern
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Timeline
- Recall initiated
- 2021-10-01
- FDA classified
- 2021-11-18
- Posted by FDA
- 2021-11-24
- Terminated
- 2023-06-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0243-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.