Dietary supplement tablets recalled for undeclared diclofenac and acetaminophen
AK Forte Ortiga y Omega 3 tablets are recalled nationwide for containing undeclared diclofenac and acetaminophen without FDA approval. Consumers should stop using this product immediately.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves an unapproved product containing undeclared pharmaceutical drugs that pose risk of serious drug interactions and adverse health effects. No illnesses or injuries have been reported, but this qualifies as a risk-of-harm product under the High severity criterion.
Plain-English summary
AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas (400 mg) is being recalled nationwide. The product was marketed without an FDA-approved New Drug Application (NDA). FDA analysis found that the supplement contains undeclared diclofenac, an anti-inflammatory drug, and acetaminophen, a pain reliever.
Consumers nationwide who purchased this product may be at risk. The undeclared pharmaceutical ingredients can cause serious drug interactions with other medications and potential adverse health effects. Diclofenac and acetaminophen are drugs that require medical guidance when used.
Consumers who have purchased AK Forte Ortiga y Omega 3 tablets should stop using the product immediately. All lots are affected. Consumers with questions or who may have experienced adverse effects should contact their healthcare provider or the FDA.
The recalled product
- Product
- AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,
- Manufacturer
- C & A Naturistics
- Category
- Drug — Dietary Supplement
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Distributed nationwide across the United States.
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