LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 58720 6, NDC 11523-0010-2; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, Packaged with LOTRIMIN ULTRA (butenafine hydrochloride 1%) cream, UPC 0 11017 40823 9, Dist by:
Check against the official notice below — it lists the full affected range.
Bayer Healthcare Pharmaceuticals Inc. is recalling LOTRIMIN AF (Tolnaftate 1%) Daily Prevention deodorant powder spray in 160g cans due to current good manufacturing practice (cGMP) deviations. The product was manufactured at a facility where other lots were found to be contaminated with benzene. The recall affects 579,456 units distributed nationwide in the US, Puerto Rico, Canada, and Mexico through various retail channels.
The affected lots are: NAA8997 (expiration 01/31/2022), NAA8EK8 (expiration 02/28/2022), and NAA9E18, NAA9LFP, NAA9T53, and NAA5RW (expiration 08/31/2022). The recall notice does not specify a remedy or recommended consumer action.
Written by software from the official notice below. Not reviewed by a lawyer.
cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.
Reason for recall: cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) 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 units Lot/code info: Lot # NAA8997, EXP 01/31/2022; NAA8EK8, EXP 02/28/2022; NAA9E18, NAA9LFP, NAA9T53, NAA5RW, EXP 08/31/2022;
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.