FDA recall D-1096-2023

Product

Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottles, UPC 0 11169 20011 8 and b) 1.85 FLUID OZ. (54.5 mL) bottles, UPC 0 11169 20012 5, Distributed by Oakhurst Company, Levittown, NY 11756.

Reason for recall

CGMP Deviations: Products not manufactured under current good manufacturing practices.

Distribution

Nationwide in the USA

Key facts

Status

Completed

Initiation date

2023-08-09

Report date

2023-08-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Norwalk, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1096-2023