Recalls / Class I
Class ID-0611-2025
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Affected lot / code info
- Lot #: 40187.2, Exp. Date 2/2026
Why it was recalled
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Recalling firm
- Firm
- DermaRite Industries, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7777 W Side Ave, N/A, North Bergen, New Jersey 07047-6436
Distribution
- Quantity
- 249 bottles
- Distribution pattern
- Nationwide within the USA
Timeline
- Recall initiated
- 2025-07-17
- FDA classified
- 2025-09-02
- Posted by FDA
- 2025-09-10
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0611-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.