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Recall Observatory FDA recall evidence

Drug product

DCL SA Scalp Therapy Shampoo (Salicylic Acid 3%) 300 ml/10.1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486503120

D-0086-2021

October 09, 2020

Class II

Product summary

Firm
Milbar Laboratories, Inc.
Event
Event 86579
Status
Terminated
Classification
Class II
Quantity
1,815 bottles
Official record key
drug-enforcement:D-0086-2021

Official wording

Reason: GMP Deviations

Code information: Lot #: KV092-3, Exp. Date Nov-21 Lot #: FX456-7, 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