Key Takeaway

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, Multinationa by Flawless Beauty LLC was recalled on April 29, 2014. The hazard: Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.

FDA Drug Class II Completed

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, Multinationa

Recalled: April 29, 2014 ~unknown units affected D-1318-2014

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

Hazard / Reason

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

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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, Multinationa

Drugs

Company Information

Flawless Beauty LLC

Asbury Park, NJ, United States

View all 18 recalls by Flawless Beauty LLC →

Distribution

Nationwide

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Frequently Asked Questions

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What remedy is available for this recall?

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Where can I find the original recall notice?

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