Home / Recalls / The Mentholatum Co. / D-0018-2016

D-0018-2016 Class II Terminated

Recalled by The Mentholatum Co. — Orchard Park, NY

Recall Details

Product Type
Drugs
Report Date
October 21, 2015
Initiation Date
September 17, 2015
Termination Date
June 6, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
80,208 pouches

Product Description

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 Pattern

Nationwide through Walmart stores.

Code Information

Lot numbers: EL016, EL 026, EL036, EL046, Expiration Date: 12/2016

Other recalls by The Mentholatum Co.

  • D-1541-2020 Class III — Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 Fl. (July 31, 2020)
  • D-1040-2014 Class II — ROHTO Cooling Eye Drops, Itch Relief, Soothes Itch & Burn, relief, Astringent, L (January 16, 2014)
  • D-1038-2014 Class II — ROHTO Redness Relief, ice, Redness Reliever, Lubricant, Astringent Eye Drops, St (January 16, 2014)
  • D-1037-2014 Class II — ROHTO Redness Relief, arctic, Redness Reliever, Lubricant Eye Drops, Sterile, Ne (January 16, 2014)
  • D-1041-2014 Class II — ROHTO Redness Relief, Cool, Redness Reliever, Lubricant Eye Drops, Sterile, Net. (January 16, 2014)
  • D-1039-2014 Class II — ROHTO Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). (January 16, 2014)