FDA recall D-0611-2025

Product

DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08

Reason for recall

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.

Distribution

Nationwide within the USA

Key facts

Status

Ongoing

Initiation date

2025-07-17

Report date

2025-09-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Bergen, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0611-2025