DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Indust...

FDA Recall #D-0611-2025 — Class I — July 17, 2025

Recall #D-0611-2025 Date: July 17, 2025 Classification: Class I Status: Ongoing

Product Description

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.

Recalling Firm

DermaRite Industries, LLC — North Bergen, NJ

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

249 bottles

Distribution

Nationwide within the USA

Code Information

Lot #: 40187.2, Exp. Date 2/2026

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated