D-0427-2025 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 28, 2025
- Initiation Date
- April 24, 2025
- Termination Date
- February 19, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,372 Tubes
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
Distribution Pattern
DE and NC
Code Information
Lot SP24A, Exp: 09/30/2026