Recalls / Class II
Class IID-0811-2018
Product
B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
- Affected lot / code info
- Lot: # ET507-0, Exp. 5/27/2019; GU894-8, Exp. 7/20/2010
Why it was recalled
Microbial Contamination of Non-sterile Product
Recalling firm
- Firm
- Milbar Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20 Commerce St, East Haven, Connecticut 06512-4145
Distribution
- Quantity
- 3,477 plastic bottles
- Distribution pattern
- Within the United States and Puerto Rico
Timeline
- Recall initiated
- 2018-05-04
- FDA classified
- 2018-05-15
- Posted by FDA
- 2018-05-23
- Terminated
- 2019-06-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0811-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.