CLASS II Drug recall · Reported 21 May 2014 · FDA Enforcement Report

Relumins Advanced Glutathione recalled by Flawless Beauty

Flawless Beauty is recalling Relumins Advanced Glutathione (lyophilized glutathione/vitamin C) injectable solution, 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

Lot, batch or date codesLot #: 130616, Exp 06/16

Quantity recalledunknown

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-1319-2014
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: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims.

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

Relumins Advanced Glutathione (lyophilized glutathione/vitamin C) injectable solution, 1500 mg/500 mg, packaged in 8-count vials, 8-count 5 mL vitamin C (ascorbic acid) solution diluent ampoules, and 30-count Advanced Glutathione Boosters capsules per box, Relumins Labs, 183 Locust Avenue, West Long Branch, NJ 07764, UPC 700175760302

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims.

Which lots are affected?

Lot #: 130616, Exp 06/16

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 68158

This 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
21 May 2014	CLASS II	Tatiomax (reduced glutathione/hydrolyzed collagen) powder recalled	Flawless Beauty	Other	Nationwide
21 May 2014	CLASS II	Sterile Water for Injection ampoules recalled by Flawless Beauty	Flawless Beauty	Packaging Defects	Nationwide
21 May 2014	CLASS II	Laroscorbine Platinium (vitamin C/collagen) injectable I.V. recalled	Flawless Beauty	Packaging Defects	Nationwide
21 May 2014	CLASS II	Saluta (reduced glutathione) Powder for Injection, 600 mg/vial recalled	Flawless Beauty	Packaging Defects	Nationwide
21 May 2014	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
14 Feb 2018Drug	CLASS II	Sterilized water for injections BP, mL plastic ampules recalled	Flawless Beauty	Labeling Errors	Nationwide
14 Feb 2018Drug	CLASS II	Saluta Glutathione Whitening kits recalled by Flawless Beauty	Flawless Beauty	Labeling Errors	Nationwide
14 Feb 2018Drug	CLASS II	TAD Glutathione Whitening Kits lyophilized powder recalled	Flawless Beauty	Labeling Errors	Nationwide
14 Feb 2018Drug	CLASS II	Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm, Roche recalled	Flawless Beauty	Labeling Errors	Nationwide
14 Feb 2018Drug	CLASS II	Reiki Glutathione Whitening kits recalled by Flawless Beauty	Flawless Beauty	Labeling Errors	Nationwide