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The National Administration of Drugs, Food and Medical Technology this Wednesday banned some first-rate condoms and a number of medical products.
He made it through the Provision 9393/2021, published in the Official Gazette, where it establishes the prohibition of the use, commercialization, withdrawal from the market and distribution throughout the national territory of the counterfeit products labeled “PRIME Textured Condoms – box of three (3) condoms – Lote – PL 1902M843 – Vto oct/23″, “PRIME Tacks Condoms – box for three (3) condoms – Lot PL 1906N142 – Maturity Oct / 23 ″ and “PRIME Superfine Condoms – box for three (3) condoms – Lot PL 1907N189 – Maturity Oct / 23 ″.
As explained, the actions were initiated following the complaint to the Market Control Department dependent on the Directorate of Evaluation and Monitoring Management of Health Products made by the technical director of the firm BUHL SA stating the detection of batches of counterfeit PRIME brand natural rubber latex male condoms.
Given this, personnel from that Directorate was present at the firm’s headquarters and the company’s technical director exhibited the counterfeit units and original counter samples in your possession for the purpose of comparative study.
It was found that the manufacturing and expiration dates of the original units did not coincide with those of the apocryphal and According to the representative of the firm, there were easily identifiable differences common to the three counterfeit batches.
Prohibited medical products
On the other hand, the organism prohibited the commercialization of all the batches and presentations of the products that are detailed below: “ATOM3 MAX. Joint pain-rheumatism-cold-blows-sprains-sciatica-bruises-tears-efforts-bruises ”; MUSHROOM ZAN FORMULA ENHANCED. Antifungal. ”; “IGUANOL FLEX. Relieve inflammation, rheumatism, muscle aches, cramps, lumbago, sciatica, catarrh, cough, bronchitis. Laboratorios Prosan SA, Moreno 55 (San Martín) MS. AND RES. 155/98. Leg. 2325. “; “VIBORIN FLEX. Relieve inflammation, rheumatism, muscle aches, cramps, lumbago, sciatica, catarrh, cough, bronchitis. Laboratorios Prosan SA, Moreno 55 (San Martín) MS. AND RES. 155/98. Leg. 2325 ″.
He made it through the Provision 9395/2021, in which it is stated that the signature Laboratorio Prosan SA, is not duly registered with ANMAT.
The authority determined that they are medications “without registration with the health authority in the Argentine Republic”, with respect to which its origin, production conditions and which therefore represents a risk to the health of potential patients to whom it might be administered are unknown.
In order to protect eventual purchasers and users of the drugs involved, and since it would be drugs without registration, the use, marketing and distribution of any product produced by the firm is prohibited until it obtains the relevant authorizations to develop and distribute its products. in the Argentine Republic.
In turn, the agency prohibited other series of medical products. In the Provision 9390/2021 determined the prohibition of products identified as: Mitral heart valve swine prosthetic No. 27 Hancock II, Medtronic Brand, Ref. T510C27, Series D069857; No. 27 Hancock II Porcine Prosthetic Mitral Heart Valve, Medtronic Brand, Ref. T510C29, Series D460891; No. 31 Hancock II Porcine Prosthetic Mitral Heart Valve, Medtronic Brand, Ref. T510C31, Series B741644; Semi-rigid Mitral Ring for annuloplasty Future No. 28, Brand Medtronic, Ref .: 638RL28, series: D561893; Semi-rigid Mitral Ring for Future annuloplasty N ° 30, Medtronic Brand, Ref .: 638RL30, series: D287374 and Semi-rigid Mitral Ring for Future annuloplasty N ° 32, Medtronic Brand, Ref .: 638RL32, series: D308442 ″ before the signature complaint DEMEDIC SOCIEDAD ANÓNIMA of theft of the same.
Meanwhile, the Provision 9392/2021 points out the same for the “SuperMix Detox Chlorella + Cilantro + Alfalfa, Makam Food brand, Packed by: Fitoperú SAC, Lima, Peru, DIGESA N7415312N” by lack of product and establishment authorization, proving to be consequently illegal.
And finally the Provision 9394/2021 establishes the prohibition of Bella Fit product, MW5 electro stimulator, Russian Waves, Square waves, TENS waves, Interferential waves, Australian waves, in the face of their lack of registration.
