ekoizpen Technicare gelditu / ordezkoak aurkitzeko

Technicare Ordezkoak

Dela egungo Technicare eskuragarri ez egotea, piercers dute zer produktu bete APP segurtasun jarraibideak azala prestatzeko buruz galdetzean dira aldez aurretik piercing to.

Betadine edo beste povidone iodo azala prep produktuak erabili ahal izango dira.

Daiteke ere, onartzen behar da ondo lehortzen piercing gertatzen aurretik, eta azalaren off cleansed behar bezeroak estudiora uzten aurretik.

Ikerketa ere erakusten batean 2% Chlorhexadine Gluconate irtenbide azala prestatzeko produktu eraginkor bat izan nahi:

Oinarritutako ikerketa ikasketak on, CDC orain biziki gomendatzen erabiliz 2% chlorhexidine azala antisepsis irtenbide. Bi-ehuneko chlorhexidine irtenbide sei aldiz erakutsi du alkohola eta povidone-iodo azala garbitzeko baino eraginkorragoa eta mikrobioen hazkundea inhibitzeko egun gutxira hasi. bi ikerketetan iraunkorrak eraginkortasuna neurtzeko, chlorhexidine demonstrated significant residual antimicrobial effect over 5 days and was more effective than isopropyl alcohol, alkohola, or povidone-iodine alone.

Hala ere, although a 2% chlorhexidine-based preparation is preferred, the CDC still considers tincture of iodine or 70% alcohol as acceptable prepping alternatives.


 

Here is the FDA news release and below that is the CARE-TECH® Laboratories press release.

FDA NEWS RELEASE

Zuzeneko oharra: Sept. 8, 2009

Media Kontsultak: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov
Kontsumo Kontsultak: 888-INFO-FDA

Care-Tech Laboratories Agrees to Stop Making, Selling and Distributing Unapproved Antimicrobial Products

The U.S. Food and Drug Administration today announced that St. Louis-based Care-Tech Laboratories Inc. and its principal officers, John C. Brereton and Sherry L. Brereton, have signed a consent decree, agreeing to stop the illegal manufacture, marketing, and distribution of over-the-counter (OTC) antimicrobial drugs used to treat and prevent infection.

Inspectors found that Care-Tech violated numerous provisions of the FDA’s current good manufacturing practice (cGMP) regulations that direct how antimicrobial drugs are made. Horrez gain, the products do not conform to any applicable regulations for OTC drug products and have not undergone an FDA review, and therefore are considered unapproved drug products.

Under the terms of the consent decree, Care-Tech may not resume manufacturing and distribution of the drugs until it corrects these and other violations.

“The FDA is concerned about Care-Tech’s products because they lack FDA approval, do not conform to any applicable over-the-counter drug monograph, and are not appropriately manufactured,” said Deborah Autor, director of the FDA’s Office of Compliance, Center for Drug Evaluation and Research. “Companies have an obligation to consumers to ensure that their products are safe, effective, and high quality, and the FDA recommends that Care-Tech’s customers seek alternative products.”

Care-Tech products are sold online and through telephone orders to hospitals, nursing homes and other health care facilities. They are not sold in retail stores. The FDA is not aware of any reports of injury or illness related to the use of these products. Consumers should contact Care-Tech at 1-800-325-9681 to return products in their possession, which include:

  • Barri-Care
  • Care-Crème
  • Caricia Care
  • CC-500
  • Clinical Care
  • Consept
  • Formula Magic
  • Humatrix
  • Loving Lather
  • Loving Lather II
  • Loving Lotion
  • Orchid Fresh II
  • Satin
  • Tech 2000
  • Techni-Care
  • Urban Skin

Health care professionals and consumers may report serious adverse events (side effects) or quality problems for these or any products to the FDA’s MedWatch Adverse Event Reporting program, online, or by regular mail, fax or phone.

Informazio gehiago nahi izanez gero:

Facts About Current Good Manufacturing Practices (cGMPs) http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm

# # #

CARE-TECH® Laboratories, Inc.

O-T-C Pharmaceuticals

Care-Tech® Laboratories, Inc. Suspends Manufacturing and Distribution of OTC Drug Products

ST. LOUIS, MO, Iraila 14, 2009/ – – Care-Tech® Laboratories, Inc. announces that it has suspended manufacturing and distribution of its drug products to address concerns raised by the U.S. Food and Drug Administration (FDA). Hain zuzen ere, the FDA has informed Care-Tech® that it believes the company’s over-the-counter (OTC) drug products have not been manufactured, prozesatu, packed, and held consistent with current good manufacturing practice for drugs, horregatik, ustezko Legeak adulterated, nahiz eta non, hemen bezala, Amaitu produktua ez dela aurkitu akastuna izan. FDA ere izan informatuta Arreta-Tech® uste duten produktu horiek ez OTC droga monografia baten adostasuna, eta, beraz, onartu gabeko drogak hartzen dira. Horrenbestez, Care-Tech® adostu ditu fabrikazio eta gure droga produktuen banaketa eten egin behar izan dugu erabat konpondu kezka horiek arte. Care-Tech® hartu du dagoeneko urrats esanguratsua gaiei ekitea FDA du gure arreta ekarri, eta estu lan egiten dugu agentzia funtzionarioek gainerako gai edozein ziurtatzeko gisa etorriak ahalik eta ebatzi.

Ezta FDA ezta Arreta-Tech® produktu horien erabilera lotutako edozein lesio edo gaixotasun txostenak jakitun da, eta FDA ez du eskatutako produktua aurrez banatzen dela ekarri du gogora. “The company is committed to ensuring that each of its products reflects the highest standards of safety and purity,” says John C. Brereton, Lehendakaria. “For over 100 urte, patient safety has been Care-Tech® Laboratories’ first and foremost commitment. And I can assure you, it remains so today.”

The company intends to update its customers as further information becomes available.