PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: May 28, 2025 Initiated: April 24, 2025 #D-0427-2025

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

Details

Units Affected
6,372 Tubes
Distribution
DE and NC
Location
Ta. Kadi, District Mehsana, N/A

Frequently Asked Questions

What product was recalled?
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.. Recalled by KENIL HEALTHCARE PRIVATE LIMITED. Units affected: 6,372 Tubes.
Why was this product recalled?
CGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on May 28, 2025. Severity: Moderate. Recall number: D-0427-2025.