Drug product
KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5% - External Analgesic), 2 oz (60 g) Jar, Distributed by: Pharmadel LLC, New Castle, DE 19720, NDC 55758-109-02, UPC 8 99711 00101 3.
D-0426-2025
Product summary
- Event
- Event 96797
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,808 Jars
- Official record key
drug-enforcement:D-0426-2025
Official wording
Reason: CGMP Deviations
Code information: Lot SP30A, Exp Date: 09/30/2026
Distribution pattern: DE and NC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations