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Recall Observatory FDA recall evidence

Drug product

Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604

D-0138-2026

September 12, 2025

Class III

Product summary

Firm
Letco Medical LLC
Event
Event 97660
Status
Ongoing
Classification
Class III
Quantity
173 500 ml bottles
Official record key
drug-enforcement:D-0138-2026

Official wording

Reason: Labeling: Not Elsewhere Classified

Code information: Batch # 24G15-T02-115604, exp. 11/30/2026

Distribution pattern: Product was distributed to: Letco Medical, LLC 1316 Commerce Drive Decatur, AL 35601 Product was further distributed to 44 compounding pharmacies and 2 distributors.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeling: Not Elsewhere Classified