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CriticalFDAfda-D-0797-2021FIRE OR BURN

Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10 goi/sachets, MATXI CORP, UPC 8 936188 880108

⚠ Critical FDA Safety Notice — Talk to Your Doctor

The FDA has flagged this as a serious safety concern (fire or burn). Do not stop, change, or discard a prescribed medication or medical device on your own. Contact your doctor or pharmacist immediately to ask whether this notice applies to your prescription and what to do next. Any specific guidance below comes directly from the FDA — Product Recall Tracker does not provide medical advice.

Category
Units Affected
35
Recall Date
August 11, 2021
Issuing Agency
Hazard
Fire Or Burn

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-0797-2021.

Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-0797-2021.

Recall terminated by FDA.

🩺 Talk to your doctor or pharmacist

Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:

  1. Do not stop, change, or discard your prescription on your own.
  2. Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
  3. Follow your clinician's guidance on whether to continue, switch, or return the product.
  4. If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
  5. For the official FDA notice, visit the FDA recalls page.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-0797-2021.

Ebay Seller - John Nguyen

FDA

About the U.S. Food and Drug Administration

The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.

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📣 Report an adverse event to the FDA (MedWatch)

If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.

How to report to FDAFile a report at FDA

Ebay Seller - John Nguyen Recall FAQ

Ebay Seller - John Nguyen is the subject of a drugs safety report: Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10 goi/sachets, MATXI CORP, UPC 8 936188 880108. The notice was published on August 11, 2021 by the U.S. Food and Drug Administration (FDA). Approximately 35 units are potentially affected.