C&A Naturistics Initiates Nationwide Voluntary Recall of AK Forte Tablets with Nettle and Omega 3 Over Undisclosed Drug Components: Diclofenac, Dexamethasone, and Methocarbamol

Summary

Company Announcement

FOR IMMEDIATE RELEASE – 10/8/24 – National City, CA, C&A Naturistics has initiated a voluntary recall of all AK Forte, 400 mg tablets, at the consumer level. The FDA’s analysis identified contamination with Diclofenac, Dexamethasone, and Methocarbamol. These substances cannot be legally marketed as dietary supplements. Thus, AK Forte tablets are an unapproved new drug without established safety or efficacy, warranting this recall.

Risk Statement: Dexamethasone is a corticosteroid used for inflammation treatment, which can impair infection resistance and lead to high blood sugar, muscle injuries, and mental health issues. Long-term or high-dose use can hinder adrenal function, with abrupt cessation potentially causing withdrawal. The presence of dexamethasone in AK Forte can lead to serious interactions with other medications. Diclofenac, a non-steroidal anti-inflammatory drug, can increase risks of cardiovascular incidents, along with gastrointestinal harms. Methocarbamol, a muscle relaxant, may induce sedation, dizziness, and low blood pressure, impairing tasks like driving. To this point, C&A Naturistics has not received reports of adverse events linked to this recall.

Marketed for joint pain and arthritis, AK Forte is packaged in a carton featuring a white, blue, red, and gold AK logo topped with a crown, containing 100 tablets. All lots have been sold nationwide through their eBay and Etsy stores.

C&A Naturistics is working to notify distributors and customers, facilitating return and replacement of all recalled products.

Consumers currently using this product should consult their healthcare professionals to safely discontinue it. Healthcare evaluation is necessary to assess withdrawal risks from corticosteroids. Only healthcare professionals can determine potential adrenal suppression in patients. Anyone possessing the recalled product should return it or dispose of it appropriately.

For inquiries related to this recall, consumers can reach the company at 619-498-9811 or via email at naturisticsca@gmail.com, Monday to Friday from 10 am to 7 pm Pacific Time. Any adverse reactions or quality issues related to this product should be reported to the FDA’s MedWatch program.

• Complete and submit reports Online
• By Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form.

The U.S. Food and Drug Administration is aware of this recall.