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Recall Observatory FDA recall evidence

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

September 17, 2015

Class II

Product summary

Firm
The Mentholatum Co.
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

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect