PHOTO from fda.gov.ph
MANILA, Philippines–The Food and Drug Administration (FDA) on Wednesday warned the public against using an unregistered injectible glutathione kit being sold online and in some derma clinics, stressing that such kind of drug product also required prescription and must be administered only by a health professional.
In its advisory, the FDA said Glutax 5GS kit and its content were not registered with the agency and thus it cannot assure that the product complied with safety, efficacy and quality standards and was manufactured strictly following the current Good Manufacturing Practice (cGMP).
Glutax 5GS kit contained Glutathione 500 mg + Alpha Lipoic Acids 200 mg (Glutax 5GS) powder for injection in a glass vial; Vitamin E 300 mg + Pro-Vitamin B3 250 mg + Pro-Vitamin B5 100 mg (Glutax 5GS) solution for injection in a glass ampule and ascorbic acid 1500mg/Collagen extract 350 mg solution for injection, also in a glass ampule, said the FDA.
“Upon determination of the [FDA], the said kit and the product it contains are confirmed to be unregistered,” said Assistant Health Secretary Nicolas Lutero III, officer in charge of the FDA.
“The public is also reminded that glutathione-containing injectibles and vitamin-containing drug products to be administered through the IM/IV route require a prescription and should be administered by healthcare practitioners,” Lutero added.
To ensure their safety, consumers were also advised to only use FDA-registered health products and to check the label for the FDA registration number or DR number.
The FDA assured the public that products with the agency’s approval had undergone the proper registration and evaluation procedures assessing their safety, efficacy and quality and ensuring that they were manufactured under the strict requirements of the cGMP.