FDA recall D-0853-2016

Keystone Laboratories Inc · Class II · drug

Product

BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. (355 ml) Bottles, Over the Counter Only. Distributed by KEYSTONE LABORATORIES, UPC 07059600430.

Reason for recall

Microbial Contamination of Non-Sterile Products: Failed S.aureus test.

Distribution

U.S. Including: MD and NJ

Key facts

Status: Terminated
Initiation date: 2016-04-04
Report date: 2016-05-25
Termination date: 2016-05-25
Voluntary/Mandated: Voluntary: Firm initiated
Location: Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0853-2016