The Recall Desk
SevereFDA (Drugs)·D-1319-2014·Announced 2014-05-21

Flawless Beauty LLC Recalls Unapproved Injectable Glutathione Solution

Flawless Beauty LLC is recalling Relumins Advanced Glutathione injectable solution because it was marketed without an approved NDA or ANDA.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe rating under the rubric for significant injury or property damage reports, or high-risk scenarios.

Plain-English summary

Flawless Beauty LLC is recalling Relumins Advanced Glutathione (lyophilized glutathione/vitamin C) injectable solution, 1500 mg/500 mg. The product is 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. The specific lot number is 130616 with an expiration date of 06/16.

The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The source text notes that the product is sold over the counter, and its labeling indicates it is to be used parenterally for drug claims.

The product was distributed nationwide. Consumers who possess this product should stop using it and contact the recalling firm for further instructions.

The recalled product

Product
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 Locu

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 130616
  • Exp 06/16

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Flawless Beauty LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →