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Recall Observatory FDA recall evidence

Drug product

Acne Shave (salicylic acid) Shave Cream Acne Shield, 0.5%, 5.1 FL OZ (150 mL) tube, Distributed by: United Exchange Corp., 17311 Valley View Blvd, Cerritos, CA 90703 USA, UPC 7 80707 73111 6.

D-0860-2018

May 25, 2018

Class II

Product summary

Firm
Shadow Holdings DBA Bocchi Labs
Event
Event 80184
Status
Terminated
Classification
Class II
Quantity
8,208 tubes
Official record key
drug-enforcement:D-0860-2018

Official wording

Reason: CGMP Deviations: products may be contaminated with bacteria.

Code information: All lots

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations