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Recall Observatory FDA recall evidence

Drug product

Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in plastic (HDPE) bottles, Over-the-counter, Model Number: 61430436 (800 mL, 12 bottles/case) - United States; Model Number: 6000179 (800 mL, 12 bottles/case) - Canada, Ecolab, St. Paul, MN 55102, NDC 47593-265-36

D-0454-2017

December 02, 2016

Class III

Product summary

Firm
Ecolab, Inc.
Event
Event 76177
Status
Terminated
Classification
Class III
Quantity
427 bottles
Official record key
drug-enforcement:D-0454-2017

Official wording

Reason: Subpotent Drug

Code information: Lot # L050261, Exp 05/18

Distribution pattern: United States, Puerto Rico and Canada

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent