FDA recall D-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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Completed

Initiation date

2014-04-29

Report date

2014-05-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Asbury Park, NJ, United States

Primary source

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