Recalls / Class II

Class IID-1318-2014

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

Affected lot / code info

Lot #: 201302275, Exp 01/20/15; 201308384, Exp 10/19/2015

Why it was recalled

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

Recalling firm

Firm

Flawless Beauty LLC

Notification channel

Press Release

Type

Voluntary: Firm initiated

Address

1215 Main St, Asbury Park, New Jersey 07712-5940

Distribution

Quantity

unknown

Distribution pattern

Nationwide

Timeline

Recall initiated

2014-04-29

FDA classified

2014-05-13

Posted by FDA

2014-05-21

Status

Completed

Source: openFDA Drug Enforcement endpoint. Recall record D-1318-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.