FDAHealthApril 24, 2025
KENIL HEALTHCARE PRIVATE LIMITED — 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
⚠️ CGMP Deviations
Is this relevant to me?
- Geography
- DE, NC
- Source agency
- FDA
- Category
- Health
- Published
- April 24, 2025
DE and NC
What's affected?
- 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.
- Lot code
- P24A
Additional details
Lot SP24A, Exp: 09/30/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 6,372 Tubes.
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