Reported May 21, 2014 · Completed

Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 10 vials per box, Exclusively Distributed…

Flawless Beauty LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Flawless Beauty LLC · 1215 Main St · Asbury Park, NJ · 07712-5940

Is this the product you have?

  • Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 10 vials per box
  • Exclusively Distributed byQAF Pharmaceuticals Inc. Philippines, Unit Unit 202 ECG Building, Multinational Avenue, Multinational Village, Parahaque City, Metro Manila Philippines
  • Manufactured byShandong Luye Pharmaceutical Co. Ltd, Yantai Shandong, PRC la Luye Pharma Subsidiary, UPC 6920425209014
Lot codes and dates
    • Lot #: 201302275
    • Exp 01/20/15
    • 201308384
    • Exp 10/19/2015
Amount recalled
unknown

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

  • Nationwide

Why it was recalled

Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 5:02 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.