Class I
Ongoing
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
This recall is currently active, issued September 10, 2025. It was issued by Dermarite Industries, Llc.
- Company
- Dermarite Industries, Llc
- Recall Initiated
- July 17, 2025
- Posted
- September 10, 2025
- Recall Number
- D-0611-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 249 bottles
- Firm Location
- North Bergen, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Distribution
Nationwide within the USA
Lot / Code Info
Lot #: 40187.2, Exp. Date 2/2026
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