Argentina's ANMAT has issued a health alert after detecting counterfeit units of the aesthetic injectable NCTF 135 HA, a Class IV medical device used for skin revitalization and wrinkle treatment. The warning, triggered by a report from product registration holder OXA PHARMA SA, highlights risks for clinics and distributors sourcing injectables in Latin America.
Counterfeit detection
OXA PHARMA SA informed ANMAT that counterfeit units labeled "NCTF 135 HA LINEDERM, LOT 2731905, vto. 2026-10" were found in the market. The company confirmed that this lot number does not match any batch produced by the original manufacturer, confirming the falsification. The product is authorized as a Class IV medical device, one of the highest risk categories, due to its implantation use for skin quality improvement.
Health risks and regulatory concerns
ANMAT stated that the origin, composition, and manufacturing conditions of the counterfeit product are unknown, so there are no guarantees of safety, efficacy, or suitability for patient use. The agency emphasized that application of these units poses a high health risk, as they may contain unauthorized substances or be produced without required quality controls. This detection raises concern in aesthetic medicine, where injectable treatments require strict oversight to avoid complications, infections, or adverse reactions.
What buyers should watch
Distributors and clinics should verify product origin through authorized channels only. ANMAT recommends not using the identified counterfeit product and contacting the agency if any suspicious units are found. Always demand documentation proving provenance, including lot identification and distributor data. Verifying the source of aesthetic products is key to protecting patient health and avoiding exposure to unguaranteed quality and safety.
Regulatory and channel signals
This alert follows a similar ANMAT warning about counterfeit Dysport, indicating a pattern of fake injectables entering the Argentine market. Importers and distributors should strengthen supply-chain checks, especially for high-risk Class IV devices. ANMAT's action underscores the importance of regulatory vigilance in Latin America, where counterfeit medical products can disrupt legitimate trade and endanger patients.
Source: Read the original report | Published: June 08, 2025