WellPatch¿ Capsaicin Pain Relief Patch, 0.025% Natural Capsaicin, External Analgesic, 4 Large Patches, Distributed by Consignor; The Mentholatum Company, Orchard Park, NY, Manufactured by Consignee; Mentholatum (China) Pharmaceuticals, Guangdong China ---

FDA recall notice · announced October 21, 2015 · The Mentholatum Co

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

WellPatch¿ Capsaicin Pain Relief Patch, 0.025% Natural Capsaicin, External Analgesic, 4 Large Patches, Distributed by Consignor; The Mentholatum Company, Orchard Park, NY, Manufactured by Consignee; Mentholatum (China) Pharmaceuticals, Guangdong China --- NDC 10742-8126-2, UPC 31074201566

Reason for recall

Labeling: Incorrect Instructions; The word not is missing from the following sentences "do bandage tightly or cover with any type of wrap except clothing and "do use with a heating pad or with other heat sources in the Drug Facts panel "Warning" section

Notes

Distribution: Nationwide through Walmart stores.
Lot/code information: Lot numbers: EL016, EL 026, EL036, EL046, Expiration Date: 12/2016
Quantity: 80,208 pouches
Status: Terminated
Products in this recall event:
- WellPatch¿ Capsaicin Pain Relief Patch, 0.025% Natural Capsaicin, External Analgesic, 4 Large Patches, Distributed by Consignor; The Mentholatum Company, Orchard Park, NY, Manufactured by Consignee; M (D-0018-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.