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Recall Observatory FDA recall evidence

Drug product

DCL B Prox10 Anti-Blemish Wash (Benzoyl Peroxide 10%), 200 ml/6.7 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 0357486500853

D-0084-2021

October 09, 2020

Class II

Product summary

Firm
Milbar Laboratories, Inc.
Event
Event 86579
Status
Terminated
Classification
Class II
Quantity
7,591 bottles
Official record key
drug-enforcement:D-0084-2021

Official wording

Reason: GMP Deviations

Code information: Lot # MV098-4, Exp. Date Dec-21 Lot #: JW995, Exp. Date Sep-22 Lot #: Fx381, Exp. Date Jun-23

Distribution pattern: Product was distributed throughout the United States, including Puerto Rico and internationally.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    GMP Deviations