D-1318-2014 Class II
Recall Details
- Product Type
- Drugs
- Report Date
- May 21, 2014
- Initiation Date
- April 29, 2014
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- unknown
Product Description
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
Reason for Recall
Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.
Distribution Pattern
Nationwide
Code Information
Lot #: 201302275, Exp 01/20/15; 201308384, Exp 10/19/2015