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Recall Observatory FDA recall evidence

Drug product

Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 8 fl. oz./236 mL, Alcohol 80% v/v, Manufactured by: Cascade Kelly Holdings LLC, NDC 80253-001-02

D-0698-2021

June 30, 2021

Class II

Product summary

Firm
Cascade Kelly Holdings LLC
Event
Event 88222
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-0698-2021

Official wording

Reason: CGMP Deviations: Does not meet monograph for denaturant.

Code information: All distributed lots within expiry

Distribution pattern: Distributed to the firm's affiliated facilities and donated third party recipients located in the following states: CT, MA, ME, ND, NY, OR, PA, TX, VT.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations