Status
Ongoing
Drug Enforcement D-0426-2025
CGMP Deviations
Classification
Class II
Report Date
May 28, 2025
Termination Date
—
Product Information
- Product description
- 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.
- Product quantity
- 11,808 Jars
- Reason for recall
- CGMP Deviations
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- DE and NC
Location & Firm
- Recalling firm
- KENIL HEALTHCARE PRIVATE LIMITED
- Address
-
Plot 319, Village Acharasan, Ankhol-Vamaj Road
India - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0426-2025
- Event ID
- 96797
- Recall initiation date
- April 24, 2025
- Center classification date
- May 19, 2025
- Code info
- Lot SP30A, Exp Date: 09/30/2026
- More code info
- —