FDA-Drug2014-05-21Class II

Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 10 vials per box, Exclusively Distributed by: QAF Pharmaceuticals Inc. Philippines, Unit Unit 202 ECG Building, Multinational Avenue, Multinational Village, Parahaque City, Metro Manila Philippines; Manufactured by: Shandong Luye Pharmaceutical Co. Ltd, Yantai Shandong, PRC la Luye Pharma Subsidiary, UPC 6920425209014

Flawless Beauty LLC
Hazard

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

Sold states
Nationwide
Affected count
unknown
Manufactured in
1215 Main St, Asbury Park, NJ, United States
Products
Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 10 vials per box, Exclusively Distributed by: QAF Pharmaceuticals Inc. Philippines, Unit Unit 202 ECG Building, Multinational Avenue, Multinational Village, Parahaque City, Metro Manila Philippines; Manufactured by: Shandong Luye Pharmaceutical Co. Ltd, Yantai Shandong, PRC la Luye Pharma Subsidiary, UPC 6920425209014

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1318-2014

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