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

Bayer Healthcare Pharmaceuticals Inc.: 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

Is my product affected?

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,

  • Brand LOTRIMIN DAILY PREVENTION DEO

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

What happened

Bayer Healthcare Pharmaceuticals Inc. is recalling Lotrimin AF Daily Prevention deodorant powder spray (tolnaftate 1%, 160g/5.6 oz cans) due to manufacturing deviations at the production facility where other lots were found to be contaminated with benzene. The affected product was distributed nationwide in the United States, Puerto Rico, Canada, and Mexico through various retail channels, totaling 579,456 cans across multiple lot numbers with expiration dates ranging from January 2022 through August 2022.

The specific recalled lots are: TN0023C (exp. 1/31/2022), TN003C7 (exp. 4/30/2022), TN00570 (exp. 7/31/2022), TN0056Z (exp. 8/31/2022), TN005KJ (exp. 8/31/2022), TN0023DV (exp. 2/28/2022), TN0023DAV (exp. 2/28/2022), TN0023DBV (exp. 2/28/2022), TN0023DC (exp. 2/28/2022), TN005KJA (exp. 8/31/2022), and TN005KJB (exp. 8/31/2022). The source document does not specify a remedy or instructions for affected consumers.

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: 579,456 cans Lot/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;

Source

Official record: FDA (Drug enforcement) ↗

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

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