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.
Reported: May 28, 2025 Initiated: April 24, 2025 #D-0426-2025
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.
Reason for Recall
CGMP Deviations
Details
- Recalling Firm
- KENIL HEALTHCARE PRIVATE LIMITED
- Units Affected
- 11,808 Jars
- Distribution
- DE and NC
- Location
- Ta. Kadi, District Mehsana, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by KENIL HEALTHCARE PRIVATE LIMITED. Units affected: 11,808 Jars.
Why was this product recalled? ▼
CGMP Deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 28, 2025. Severity: Moderate. Recall number: D-0426-2025.
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