Drug product
BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. (355 ml) Bottles, Over the Counter Only. Distributed by KEYSTONE LABORATORIES, UPC 07059600430.
D-0853-2016
Product summary
- Event
- Event 73895
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 Cases of 12 Bottles
- Official record key
drug-enforcement:D-0853-2016
Official wording
Reason: Microbial Contamination of Non-Sterile Products: Failed S.aureus test.
Code information: Lot #: 10AN5
Distribution pattern: U.S. Including: MD and NJ
Derived failure modes
-
Microbial contamination
Microbial Contamination