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Recall Observatory FDA recall evidence

Drug product

Bersih Hand Sanitizer Gel, Net wt. 16.9 floz (500ml), Blue and Green cap) Distributed by RediBag USA 135 Fulton Ave New Hyde Park, NY 11040 UPC 8 16822 02666 7

D-1560-2020

July 14, 2020

Class II

Product summary

Firm
Soluciones Cosmeticas, SA de CV
Event
Event 86042
Status
Terminated
Classification
Class II
Quantity
2,486,400 bottles
Official record key
drug-enforcement:D-1560-2020

Official wording

Reason: cGMP Deviations

Code information: All lots remaining within expiry.

Distribution pattern: United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations