Drug 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
D-0611-2025
Product summary
- Event
- Event 97277
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 249 bottles
- Official record key
drug-enforcement:D-0611-2025
Official wording
Reason: Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Code information: Lot #: 40187.2, Exp. Date 2/2026
Distribution pattern: Nationwide within the USA
Derived failure modes
-
Microbial contamination
Microbial Contamination