FDAClass IINovember 24, 2021

Tinactin recall: CGMP Deviations

Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Ireland…

Why was Tinactin recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # TN00086, CV015YU, EXP 10/31/2022; TN00273, EXP 12/31/2022; TN005RW, Exp 5/31/2023;

Product
Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Ireland…
Recalling firm
Bayer Healthcare Pharmaceuticals Inc.
Quantity
592,416 cans
Distribution
Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Recall date
November 24, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls