WellPatch¿ Capsaicin Pain Relief Patch, 0.025% Natural Capsaicin, External Analgesic, 4 Large Pat...

FDA Drug Recall #D-0018-2016 — Class II — September 17, 2015

Recall Summary

Recall Number D-0018-2016
Classification Class II — Moderate risk
Date Initiated September 17, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm The Mentholatum Co.
Location Orchard Park, NY
Product Type Drugs
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.

Lot / Code Information

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

Other Recalls from The Mentholatum Co.

Recall # Classification Product Date
D-1040-2014 Class II ROHTO Cooling Eye Drops, Itch Relief, Soothes I... Jan 16, 2014
D-1039-2014 Class II ROHTO Dry Eye, hydra, Lubricant Eye Drops, Ster... Jan 16, 2014
D-1037-2014 Class II ROHTO Redness Relief, arctic, Redness Reliever,... Jan 16, 2014
D-1038-2014 Class II ROHTO Redness Relief, ice, Redness Reliever, Lu... Jan 16, 2014
D-1041-2014 Class II ROHTO Redness Relief, Cool, Redness Reliever, L... Jan 16, 2014

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.