FDA recall D-0018-2016

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

Distribution

Nationwide through Walmart stores.

Key facts

Status

Terminated

Initiation date

2015-09-17

Report date

2015-10-21

Termination date

2018-06-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Orchard Park, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0018-2016