After being targeted for an FDA inspection earlier this year, Pain Relief Naturally has announced a recall covering all lot codes of 3 of its products:
- Naturally HL Bedsore Relief Cream
- Extra Strength PreTAT by TAT Balm Carbomer Free Gel
- Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine
In its press release about the recall, Pain Relief Naturally acknowledges that agents with the U.S. Food and Drug Administration, or FDA, found numerous “serious violations” related to its manufacturing and marketing practices during the multi-day inspection.
According to the official FDA warning letter sent to the company last month, those alleged violations included things like:
- Pain Relief Naturally admitted to not testing any of the now-recalled products for strength or even to confirm that the actual ingredients are what they are suppose to be.
- The company also did not test for microbial contamination, despite the products being hawked for wound care, like bed sores and new tattoos.
- The company failed to properly investigate “more than 50” complaints about a particular product that FDA tests later found to be, as the agency puts it, subpotent.
- The company uses common kitchen utensils instead of professional tools and equipment. It also neglected to isolate the manufacturing part of the business, posing a risk for “contamination or mix-ups”.
Violations like these, says FDA, suggest that the folks at Pain Relief Naturally, “lack understanding of the basic elements of a compliant manufacturing operation”.
Multiple alleged violations were also found in respect to the company’s marketing and labeling, as well.
Pain Relief Naturally is based in Salem, Oregon. It is owned by John Durig and is a DBA of Durig’s company, Ridge Properties. Pain Relief Naturally products are extensively marketed; they are (or were) available at websites like Amazon and eBay, as well as Durig’s own websites like PainReliefNaturally.co, NaturallyHL.com and TatBalm.net.
As of my last visit to those websites, only TatBalm.com actually appeared to link to a recall notice, which was in a small black font and placed under a much larger testimonial in white text: