KOFAL, Athletes, Penetrating Pain Relief, External recall: CGMP Deviations
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.
Why was KOFAL, Athletes, Penetrating Pain Relief, External recalled?
CGMP Deviations
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot SP30A, Exp Date: 09/30/2026
- Product
- 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.
- Recalling firm
- KENIL HEALTHCARE PRIVATE LIMITED
- Quantity
- 11,808 Jars
- Distribution
- DE and NC
- Recall date
- May 28, 2025
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)