CLASS II Drug recall · Reported 21 May 2014 · FDA Enforcement Report
Saluta (reduced glutathione) Powder for Injection, 600 mg/vial recalled
Flawless Beauty is recalling Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, distributed nationwide in the US. The recall was initiated on 29 Apr 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1318-2014
- FDA event ID
- 68158
- Recalling firm
- Flawless Beauty, Asbury Park, NJ
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 29 Apr 2014
- FDA classified
- 13 May 2014
- Reported
- 21 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 29 Apr 2014 | Recall initiated by company | |
| 13 May 2014 | Classified by FDA | +14 days |
| 21 May 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.
Which lots are affected?
Lot #: 201302275, Exp 01/20/15; 201308384, Exp 10/19/2015
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 68158This product is part of a recall event; the main page for the event is Tatiomax (reduced glutathione/hydrolyzed collagen) powder recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Tatiomax (reduced glutathione/hydrolyzed collagen) powder recalled | Flawless Beauty | Other | Nationwide | |
| CLASS II | Sterile Water for Injection ampoules recalled by Flawless Beauty | Flawless Beauty | Packaging Defects | Nationwide | |
| CLASS II | Relumins Advanced Glutathione recalled by Flawless Beauty | Flawless Beauty | Packaging Defects | Nationwide | |
| CLASS II | Laroscorbine Platinium (vitamin C/collagen) injectable I.V. recalled | Flawless Beauty | Packaging Defects | Nationwide | |
| CLASS II | Vitamin C (ascorbic acid) Injection, USP, 500 mg recalled | Flawless Beauty | Other | Nationwide |
More recalls from Flawless Beauty
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sterilized water for injections BP, mL plastic ampules recalled | Flawless Beauty | Labeling Errors | Nationwide |
| Drug | CLASS II | Saluta Glutathione Whitening kits recalled by Flawless Beauty | Flawless Beauty | Labeling Errors | Nationwide |
| Drug | CLASS II | TAD Glutathione Whitening Kits lyophilized powder recalled | Flawless Beauty | Labeling Errors | Nationwide |
| Drug | CLASS II | Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm, Roche recalled | Flawless Beauty | Labeling Errors | Nationwide |
| Drug | CLASS II | Reiki Glutathione Whitening kits recalled by Flawless Beauty | Flawless Beauty | Labeling Errors | Nationwide |