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.
Reported: May 28, 2025 Initiated: April 24, 2025 #D-0425-2025
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.
Reason for Recall
CGMP Deviations
Details
- Recalling Firm
- KENIL HEALTHCARE PRIVATE LIMITED
- Units Affected
- 16,248 Jars
- Distribution
- DE and NC
- Location
- Ta. Kadi, District Mehsana, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by KENIL HEALTHCARE PRIVATE LIMITED. Units affected: 16,248 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-0425-2025.
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