Saluta — Class II drug recall D-1318-2014
Completed recall by Flawless Beauty LLC, reported 2014-05-21, distributed nationwide. Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.
| Recall number | D-1318-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Flawless Beauty LLC, Asbury Park, NJ, United States |
| Recall initiated | 2014-04-29 |
| Classified | 2014-05-13 |
| Reported by FDA | 2014-05-21 |
| Distributed | Nationwide (US) |
| Reason classes | labeling, unapproved product |
| UPC / GTIN / UDI-DI | 06920425209014 |
| Lot numbers | 201302275, 201308384 |
| Expiration dates | 2015-01-20, 2015-10-19 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1318-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.