Safety Alerts and Products Recalls > Products found to contain undeclared medicines

Products found to contain undeclared medicines   The United States: C&A Naturistics issues voluntary nationwide recall of AK Forte Tablets con Ortiga y Omega 3 due to the presence of undeclared drug ingredients: diclofenac, dexamethasone, and methocarbamol   The United States Food and Drug Administration (FDA) announces that 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. 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. Please refer to the following website in FDA for details: http://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 In Hong Kong, the above product is not a registered pharmaceutical product. Ends/Thursday, Oct 17, 2024 Issued at HKT 15:30