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
Reported: May 21, 2014 Initiated: April 29, 2014 #D-1318-2014
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.
Details
- Recalling Firm
- Flawless Beauty LLC
- Units Affected
- unknown
- Distribution
- Nationwide
- Location
- Asbury Park, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Flawless Beauty LLC. Units affected: unknown.
Why was this product recalled? ▼
Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 21, 2014. Severity: Moderate. Recall number: D-1318-2014.
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