Optim V recalled over manufacturing violations
- Recall date
- April 24, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- KENIL HEALTHCARE PRIVATE LIMITED recalls Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External analgesic, Net Wt. Peso Neto 1 oz (28g) Tube, Distr…
- Recall number
- D-0427-2025
- FDA classification
- Class II
- Brand / firm
- KENIL HEALTHCARE PRIVATE LIMITED
- Sold / distributed
- DE and NC
Why it was recalled
CGMP Deviations
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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.
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