D-0611-2025 Class I Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- September 10, 2025
- Initiation Date
- July 17, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 249 bottles
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.
Distribution Pattern
Nationwide within the USA
Code Information
Lot #: 40187.2, Exp. Date 2/2026