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Recall Observatory FDA recall evidence

Drug product

DCL Alpha Beta Gel Toner (1.95% Salicylic Acid) 200 mL/6.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA

D-0094-2021

October 09, 2020

Class II

Product summary

Firm
Milbar Laboratories, Inc.
Event
Event 86579
Status
Terminated
Classification
Class II
Quantity
2,335 bottles
Official record key
drug-enforcement:D-0094-2021

Official wording

Reason: GMP Deviations

Code information: Lot # HV093-6, exp. date Aug-21

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