Class II
Drug Recall: 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,
KENIL HEALTHCARE PRIVATE LIMITED · April 24, 2025
Reason for Recall
CGMP Deviations
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.
Distribution
DE and NC
States Affected
DE, NC
Quantity Affected
6,372 Tubes
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0427-2025
Status: terminated
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