Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External analgesic, Net Wt. Peso Neto ...
FDA Recall #D-0427-2025 — Class II — April 24, 2025
Product Description
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
Recalling Firm
KENIL HEALTHCARE PRIVATE LIMITED — Ta. Kadi, District Mehsana, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
6,372 Tubes
Distribution
DE and NC
Code Information
Lot SP24A, Exp: 09/30/2026
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated