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
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
Lot numbers, UPCs & expiration codes
Lot numbers: EL016, EL 026, EL036, EL046, Expiration Date: 12/2016
Where it was sold
Nationwide through Walmart stores.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0018-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 17, 2015
- FDA report date
- Oct 21, 2015
- Quantity
- 80,208 pouches
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Mentholatum Co.
Original FDA data
Every field from FDA enforcement report D-0018-2016, exactly as published.
Show all FDA fields
- City
- Orchard Park
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 72246
- Address
- 707 Sterling Drive
- Code information
- Lot numbers: EL016, EL 026, EL036, EL046, Expiration Date: 12/2016
- Postal code
- 14127
- Report date
- Oct 21, 2015
- Product type
- Drugs
- Recall number
- D-0018-2016
- Classification
- Class II
- Recalling firm
- The Mentholatum Co.
- Product quantity
- 80,208 pouches
- Termination date
- Jun 6, 2018
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide through Walmart stores.
- Recall initiation date
- Sep 17, 2015
- Initial firm notification
- Telephone
- Center classification date
- Oct 14, 2015