Status
Ongoing
Drug Enforcement D-0425-2025
CGMP Deviations
Classification
Class II
Report Date
May 28, 2025
Termination Date
—
Product Information
- Product description
- 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.
- Product quantity
- 16,248 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-0425-2025
- Event ID
- 96797
- Recall initiation date
- April 24, 2025
- Center classification date
- May 19, 2025
- Code info
- Lost SP21A, Exp Date: 03/31/2026
- More code info
- —