Drug 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
D-0018-2016
Product summary
- Event
- Event 72246
- Status
- Terminated
- Classification
- Class II
- Quantity
- 80,208 pouches
- Official record key
drug-enforcement:D-0018-2016
Official wording
Reason: 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
Code information: Lot numbers: EL016, EL 026, EL036, EL046, Expiration Date: 12/2016
Distribution pattern: Nationwide through Walmart stores.
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect