CLASS II Drug recall · Reported 14 Feb 2018 · FDA Enforcement Report
Saluta Glutathione Whitening kits recalled by Flawless Beauty
Flawless Beauty is recalling Saluta Glutathione Whitening kits, distributed nationwide in the US. The recall was initiated on 19 Jan 2018 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-0334-2018
- FDA event ID
- 78991
- Recalling firm
- Flawless Beauty, Asbury Park, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Jan 2018
- FDA classified
- 5 Feb 2018
- Reported
- 14 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
- Drug class
- Injectable & IV Drugs
Timeline
| 19 Jan 2018 | Recall initiated by company | |
| 5 Feb 2018 | Classified by FDA | +17 days |
| 14 Feb 2018 | Published in enforcement report | +9 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: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
Product as listed by the FDA
Saluta Glutathione Whitening kits, packaged in 600 mg, 1200 mg and 1800 mg glass vials, Manufactured by: Shandong Luye Pharmaceutical Co, Ltd, Yantai, Shandong. PRC
Where it was distributed
Product was distributed U.S.A. nationwide.
Questions about this recall
Why was it recalled?
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
Which lots are affected?
all lots
Where was it sold?
Product was distributed U.S.A. 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 21 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
11 other products · FDA event 78991This product is part of a recall event; the main page for the event is Ling Zhi capsules recalled by Flawless Beauty.
More recalls from Flawless Beauty
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|---|---|---|---|---|---|
| Drug | CLASS II | Sterilized water for injections BP, mL plastic ampules recalled | 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 |
| Drug | CLASS II | Laennec INJ, Placenta extract (human) vials recalled by Flawless Beauty | Flawless Beauty | Labeling Errors | Nationwide |