FDA Alert: Pain Relief-Marketed Dietary Supplement Recalled For Containing Prescription Steroids, Muscle Relaxants, and OTC Pain Relievers

Company Announcement

FOR IMMEDIATE RELEASE – 10/8/24 – National City, CA, C&A Naturistics is voluntarily recalling all lots of AK Forte, 400 mg tablets, to the consumer level. FDA analysis has found the product to be tainted Diclofenac, Dexamethasone, and Methocarbamol. Products containing diclofenac, dexamethasone, and methocarbamol cannot be marketed as dietary supplements. AK Forte tablets is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.

Risk Statement: Dexamethasone is a corticosteroid commonly used to treat inflammatory conditions. Corticosteroid use can impair a person’s ability to fight infections and can cause high blood sugar levels, muscle injuries and psychiatric problems. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland. Abrupt discontinuation can cause withdrawal symptoms. In addition, the undeclared dexamethasone in AK Forte may cause serious side effects when combined with other medications. Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products. Methocarbamol is a muscle relaxant that can cause sedation, dizziness, and low blood pressure. Methocarbamol can also impair mental and physical abilities to perform certain tasks, such as driving a motor vehicle or operating machinery. To date, C&A Naturistics has not received any reports of adverse events related to this recall.

AK Forte is marketed as a dietary supplement for Joint pain and Arthritis and is packaged in a cardbox type of packaging, with white, blue, red and gold logo of AK with a gold crown on top with 100 tablets per units, and all codes. The affected product AK Forte, all lots were distributed Nationwide via our Ebay and Etsy store.

C&A Naturistics is notifying its distributors and customers and is arranging for return/replacement etc. of all recalled products.

Consumers taking this product should immediately consult with their health care professional to safely discontinue use of this product. The risks of withdrawal from corticosteroids should be assessed by a healthcare professional. Only licensed health care professionals can evaluate patients for the risk, or confirm the existence, of adrenal suppression. Consumers that have product which is being recalled should return to place of purchase or discard.

Consumers with questions regarding this recall can contact Company by phone 619-498-9811 or naturisticsca@gmail.com M-F 10am-7pm Pacific standard zone. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.