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Recall Observatory FDA recall evidence

Drug product

Salicylic Acid Shampoo 3%, Bulk Product, 360 Therapeutics

D-0096-2021

October 09, 2020

Class II

Product summary

Firm
Milbar Laboratories, Inc.
Event
Event 86579
Status
Terminated
Classification
Class II
Quantity
198.8 kg
Official record key
drug-enforcement:D-0096-2021

Official wording

Reason: GMP Deviations

Code information: Lot #: HV349

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