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The FDA advises the public against purchasing or using three unregistered drug products: 1) Gluta Essencial Snow White Drip, 2) Gluta Essencial Cinderella Infusion Drip, and 3) Gluta Essencial Celestial Infusion Drip. The FDA has verified that these products did not go through the proper registration process and were not issued certificates of product registration, so the FDA cannot guarantee their quality, safety or efficacy. Entities are warned not to distribute these violative drug products until they have the proper authorization from the FDA.

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49 views

PDF Document 14 PDF

The FDA advises the public against purchasing or using three unregistered drug products: 1) Gluta Essencial Snow White Drip, 2) Gluta Essencial Cinderella Infusion Drip, and 3) Gluta Essencial Celestial Infusion Drip. The FDA has verified that these products did not go through the proper registration process and were not issued certificates of product registration, so the FDA cannot guarantee their quality, safety or efficacy. Entities are warned not to distribute these violative drug products until they have the proper authorization from the FDA.

Uploaded by

Earl Gino Macuha
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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FDA Advisory
No.2022-1633 ||
Public Health Warning
Against the Purchase
and Use of the
Following Unregistered
Drug Products:
Share this Post!

   

The Food and Drug Administration (FDA) advises the


public against the purchase and use of the following
unregistered drug products:

1. Gluta Essencial Snow White Drip 25,000,000 mg


Glutathione, 1,200 mg Kojic Acid, 600mg Coenzyme
Q10, Nano Concentrated Multivitamins I.M / I.V
2. Gluta Essencial Cinderella Infusion Drip 3,000,000mg
Ultra Concentrated Glutathione, 80,000mg Multivitamin
Complex, 700mg Polydeoxyribonucleotide (PDRN) I.M /
I.V 25ml
3. Gluta Essencial Celestial Infusion Drip 2,500,000 mg
Glutathione, 800 mg Alpha Lipoic Acid, 600 mg Kojic
Acid, 3600 mg Whitening Booster I.M / I.V

FDA Post-Marketing Surveillance (PMS) activities have


verified that the abovementioned drug products have
not gone through the registration process of the Agency
and have not been issued with proper authorization in
the form of Certificate of Product Registration. Thus,
the Agency cannot guarantee their quality, safety and
efficacy. Therefore, consumption of such violative
products may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as


the “Food and Drug Administration Act of 2009”, the
manufacture, importation, exportation, sale, offering for
sale, distribution, transfer, promotion, advertising or
sponsorship of health products without proper
authorization from FDA is prohibited.

All concerned establishments and/or entities are warned


not to distribute the above-identified violative drug
products until they have already been covered by the
appropriate authorization, otherwise, regulatory actions
and sanctions shall be strictly pursued. Always check if
the products are registered with the FDA by using the
FDA Verification Portal feature accessible at
https://verification.fda.gov.ph.

All Local Government Units (LGUs) and Law


Enforcement Agencies (LEAs) are requested to ensure
that these products are not sold or made available in
their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at


[email protected]. To report continuous sale or
distribution of unregistered health products, kindly e-
mail us via [email protected]. You may also call the
Center for Drug Regulation and Research at telephone
number (02) 8809-5596. For any suspected adverse
drug reaction (ADR), report immediately to FDA through
this link: https://primaryreporting.who-
umc.org/Reporting/Reporter?OrganizationID=PH and fill
out all the required fields.

Dissemination of the information to all concerned is


requested.

Attachments
 FDA Advisory No.2022-1633
SHARES
 (867 kB)

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