FDA-Drug2025-05-28Class II
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.
KENIL HEALTHCARE PRIVATE LIMITED
Hazard
CGMP Deviations
Sold states
DE and NC
Affected count
6,372 Tubes
Manufactured in
Plot 319, Village Acharasan, Ankhol-Vamaj Road, Ta. Kadi, District Mehsana, N/A, India
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0427-2025Don't want to check this manually?
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