Drug Enforcement D-0611-2025

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

Status

Ongoing

Classification

Class I

Report Date

September 10, 2025

Termination Date

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Product Information

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
Product quantity
249 bottles
Reason for recall
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within the USA

Location & Firm

Recalling firm
DermaRite Industries, LLC
Address
7777 W Side Ave, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0611-2025
Event ID
97277
Recall initiation date
July 17, 2025
Center classification date
September 2, 2025
Code info
Lot #: 40187.2, Exp. Date 2/2026
More code info
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