Skip to content
Recall Observatory FDA recall evidence

Drug product

Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-423-15, UPC 8 10096 77163 6.

D-0424-2025

April 24, 2025

Class II

Product summary

Firm
KENIL HEALTHCARE PRIVATE LIMITED
Event
Event 96797
Status
Terminated
Classification
Class II
Quantity
9,000 Bottles
Official record key
drug-enforcement:D-0424-2025

Official wording

Reason: CGMP Deviations

Code information: Lot SP28A, Exp Date: 09/30/2026

Distribution pattern: DE and NC

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations