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Recall Observatory FDA recall evidence

Drug product

Walker Hand Sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70%, 32 oz and 16 oz, Topical Solution, Walker Emulsions Inc., 4401 SE Johnson Creek Blvd., Portland, OR 97222, NDC 74940-0415-1

D-1417-2020

June 03, 2020

Class II

Product summary

Firm
WALKER EMULSIONS INC
Event
Event 85955
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-1417-2020

Official wording

Reason: Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.

Code information: Lot # 210061

Distribution pattern: US Distribution: Product distributed to sister plant site located in SC, and one donation made to consignee located in OR. Majority of hand sanitizer shipped to Canada (Health Canada has already received consignee information and classified the recall).

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.