A reasonable chance it could cause serious harm or death.
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
| Distributed by / for | DermaRite Industries, LLC |
| NDC | 61924-189-08 |
| Full product label | 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 |
| Recalling firm | DermaRite Industries, LLC |
| Distribution | Nationwide within the USA |
| Quantity | 249 bottles |
| Recall initiated | 2025-07-17 |
| Report date | 2025-09-10 |
| Recall completed | — |
| Recall number | D-0611-2025 |
| Classification | Class I |
| FDA status | Ongoing |
| Origin on file | North Bergen NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗