FDA recall D-0427-2025

KENIL HEALTHCARE PRIVATE LIMITED · Class II · drug

Product

Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External analgesic, Net Wt. Peso Neto 1 oz (28g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-300-01, UPC 8 59424 00420 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-0427-2025