Drug product
B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
D-0811-2018
Product summary
- Event
- Event 80042
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,477 plastic bottles
- Official record key
drug-enforcement:D-0811-2018
Official wording
Reason: Microbial Contamination of Non-sterile Product
Code information: Lot: # ET507-0, Exp. 5/27/2019; GU894-8, Exp. 7/20/2010
Distribution pattern: Within the United States and Puerto Rico
Derived failure modes
-
Microbial contamination
Microbial Contamination