Drug product
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
D-1318-2014
Product summary
- Event
- Event 68158
- Status
- Completed
- Classification
- Class II
- Quantity
- unknown
- Official record key
drug-enforcement:D-1318-2014
Official wording
Reason: Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.
Code information: Lot #: 201302275, Exp 01/20/15; 201308384, Exp 10/19/2015
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.