FDA recall D-0425-2025
KENIL HEALTHCARE PRIVATE LIMITED · Class II · drug
Product
KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4 oz (113 g) Jar, Distributed by: Pharmadel LLC, Georgetown, DE 199747, NDC 55758-106-04, UPC 8 9971100128 0.
Reason for recall
CGMP Deviations
Distribution
DE and NC
Key facts
- Status
- Terminated
- Initiation date
- 2025-04-24
- Report date
- 2025-05-28
- Termination date
- 2026-02-19
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Ta. Kadi, District Mehsana, N/A, India
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0425-2025