Recalls / Class II
Class IID-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
- Affected lot / code info
- Lot numbers: EL016, EL 026, EL036, EL046, Expiration Date: 12/2016
Why it was recalled
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
Recalling firm
- Firm
- The Mentholatum Co.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 707 Sterling Drive, N/A, Orchard Park, New York 14127
Distribution
- Quantity
- 80,208 pouches
- Distribution pattern
- Nationwide through Walmart stores.
Timeline
- Recall initiated
- 2015-09-17
- FDA classified
- 2015-10-14
- Posted by FDA
- 2015-10-21
- Terminated
- 2018-06-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0018-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.