FDA Drug Recalls

Recalls / Class II

Class IID-0091-2021

Product

MD Complete Breakout Treatment (Benzoyl Peroxide 4.5%) 1 fl. oz. (30mL) bottles, MD Professional LLC, Minneapolis, MN

Affected lot / code info
Lot #: DX278, Exp. Date Apr-23

Why it was recalled

GMP Deviations

Recalling firm

Firm
Milbar Laboratories, Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
20 Commerce St, N/A, East Haven, Connecticut 06512-4145

Distribution

Quantity
2,655 bottles
Distribution pattern
Product was distributed throughout the United States, including Puerto Rico and internationally.

Timeline

Recall initiated
2020-10-09
FDA classified
2020-11-17
Posted by FDA
2020-11-25
Terminated
2023-01-04
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0091-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.