FDA recall D-0424-2025

KENIL HEALTHCARE PRIVATE LIMITED · Class II · 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.

Reason for recall

CGMP Deviations

Distribution

DE and NC

Key facts

Status
Terminated
Initiation date
2025-04-24
Report date
2025-05-28
Termination date
2026-02-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ta. Kadi, District Mehsana, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0424-2025