TOPIC: AK Forte Tablets con Ortiga y Omega 3 by C&A Naturistics: Recall - Due to the Presence of Undeclared Drug Ingredients: Diclofenac, Dexamethasone, and Methocarbamol
AUDIENCE: Consumer, Patient, Health Professional, Rheumatology
ISSUE: C&A Naturistics is recalling all lots of AK Forte 400 mg tablets because FDA analysis has found the product to be tainted with 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.
For more information about this recall, click on the red button Read Recall below.
BACKGROUND: AK Forte is marketed as a dietary supplement for joint pain and arthritis.
RECOMMENDATIONS:
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Consumers/patients 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 health care professional. Only licensed health care professionals can evaluate patients for the risk, or confirm the existence, of adrenal suppression.
- Consumers/patients should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.
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Consumers/patients that have product which is being recalled should return to place of purchase or discard.
- Consumers/patients with questions regarding this recall can contact the company by phone at 619-498-9811 or by email at naturisticsca@gmail.com.
- C&A Naturistics is notifying its distributors and customers and is arranging for return/replacement etc. of all recalled products.
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