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FDA (Drug enforcement)Recalled 2021-10-01closedclass ii

Bayer Healthcare Pharmaceuticals Inc.: 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 Irelan

Is my product affected?

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

  • Brand TINACTIN

Check against the official notice below — it lists the full affected range.

What happened

Bayer Healthcare Pharmaceuticals Inc. is recalling Tinactin (Tolnaftate 1%) Liquid Spray in 150g (5.3 oz) cans due to manufacturing deviations at the production facility where other lots were found to be contaminated with benzene. The recalled products were distributed nationwide in the US, Puerto Rico, Canada, and Mexico through various retail channels, affecting approximately 4,990,860 cans across multiple lot numbers with expiration dates ranging from October 2021 through February 2023. The affected lots include products labeled as manufactured in Finland and Ireland.

The source document does not specify a remedy or recommended action for consumers with recalled product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. Distribution: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels. Quantity: 4,990,860 cans 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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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