Safety Report: AK Forte Dietary Supplement - recalled due to unapproved drug, USA

United States

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. The affected product AK Forte, all lots were distributed nationwide via our Ebay and Etsy store in USA.

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 can also impair mental and physical abilities to perform certain tasks, such as driving a motor vehicle or operating machinery.

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.

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. Consumers that have product which is being recalled should return to place of purchase.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: C&A Naturistics
Brand name: AK Forte
Product recalled: AK Forte Dietary Supplement
Reason of the recall: Device & Drug Safety – Unapproved Drug
FDA Recall date: October 16, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ca-naturistics-issues-voluntary-nationwide-recall-ak-forte-tablets-con-ortiga-y-omega-3-due-presence