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Recall Observatory FDA recall evidence

Drug product

Hand Sanitizer (Alcohol 80% v/v) topical solution, 55 US GAL (208 L) EcoLab Inc 1 EcoLab Place St. Paul, MN 55102 USA, NDC 47593-624-21

D-1539-2020

July 30, 2020

Class II

Product summary

Firm
Ecolab Inc
Event
Event 86246
Status
Terminated
Classification
Class II
Quantity
305 drums
Official record key
drug-enforcement:D-1539-2020

Official wording

Reason: Discoloration and Presence of Foreign Substance

Code information: Lot #: BP0D3091A0, BP0D3203A0, CR0D0553A0, CR0D0571A0, CR0D0577A0, CR0D0584A0, CR0E0482A0, CR0E0490A0, CR0E0499A0, CR0E0501A0, CR0E0520A0, FO0D0358A0, FO0D0440A0, FO0D0456A0, FO0D0464A0, FO0D0480A1, FO0D0490A0, FO0D0502A1, FO0D0517A1, FO0E0044A1, FO0E0061A1, FO0E0075A1, FO0E0094A0, FO0E0111A0, FO0E0119A1, FO0E0241A1, FO0E0256A1; Exp. Date April 2021

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Substance