← FDA ENFORCEMENT
D-0611-2025Class I

DermaRite Industries, LLC

Recalling firm
DermaRite Industries, LLC
Product type
Drug
Status
Ongoing
Report date
2025-09-10
Distribution
Nationwide within the USA
Firm state
NJ
Product quantity
249 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

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

Code / lot info

Lot #: 40187.2, Exp. Date 2/2026

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.