Drug recall: Relumins Advanced Glutathione kits, 900 mg vials, 1500 mg vials and 3000 mg vials
Class II FDA enforcement event 78991. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Flawless Beauty LLC started this drug recall on 19 Jan 2018. The firm address in the FDA record is in Asbury Park, NJ. FDA put the recall in Class II. FDA event 78991 has 12 product records. The first FDA enforcement report date is 14 Feb 2018. The record gives the status Terminated, with the termination date 13 Sep 2018.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Product was distributed U.S.A. nationwide.
Recalling firm
Flawless Beauty LLC, Asbury Park, NJ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
12 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0324-2018 | Relumins Advanced Glutathione kits, 900 mg vials, 1500 mg vials and 3000 mg vials | N/A | Class II | Terminated | 14 Feb 2018 |
| D-0325-2018 | Relumins Vitamin C Solvent ampules | N/A | Class II | Terminated | 14 Feb 2018 |
| D-0326-2018 | Tatiomax Gluatathione Whitening kits, 1400mg vials, Made in Japan | N/A | Class II | Terminated | 14 Feb 2018 |
| D-0327-2018 | Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm, Roche | N/A | Class II | Terminated | 14 Feb 2018 |
| D-0328-2018 | Tationil Glutathione, 600 mg/ 4 mL, polvere e solvente per soluzione iniettabile, Teofarma, s.r.l. | N/A | Class II | Terminated | 14 Feb 2018 |
| D-0329-2018 | Laennec INJ, Placenta extract (human), 2mL vials, Manufactured by: GCJBP Corp, Korea | N/A | Class II | Terminated | 14 Feb 2018 |
| D-0330-2018 | Reiki Glutathione Whitening kits | N/A | Class II | Terminated | 14 Feb 2018 |
| D-0331-2018 | TP Drug Laboratories Vitamin C ampules | N/A | Class II | Terminated | 14 Feb 2018 |
| D-0332-2018 | Sterilized water for injections BP, 50 x 5 mL plastic ampules, Manufactured in India | N/A | Class II | Terminated | 14 Feb 2018 |
| D-0333-2018 | Ling Zhi capsules | N/A | Class II | Terminated | 14 Feb 2018 |
| D-0334-2018 | 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 | N/A | Class II | Terminated | 14 Feb 2018 |
| D-0335-2018 | TAD Glutathione Whitening Kits lyophilized powder for injection, 600 mg vials, 10 vials + 10 amps x 4 mL, Manufactured by: Biomedica Foscama Industria, Ferentino, Italy | N/A | Class II | Terminated | 14 Feb 2018 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2018
- 367
- Share of these events in Class II
- 60%
- Product records in this event
- 12Median of the firm: 12
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 29 Apr 2014 | Laroscorbine Platinium (vitamin C/collagen) injectable I.V. solution, 1 gm/0.35 gm, 5 mL ampoules, packaged in 10-count | Drug | Class II | 6 |
Official channels
- FDA enforcement report D-0324-2018The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 78991. https://recallregister.com/fda/ii/78991/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Product was distributed U.S.A. nationwide.
- What quantity of product is in FDA event 78991?
- The event has 12 product records. The first record gives this quantity:
N/A
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2018 have the same class?
- 60% of the 367 drug events that started in 2018 are in Class II.