FDAClass IIMay 21, 2014

Relumins Advanced Glutathione recall: Labeling Error

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

Why was Relumins Advanced Glutathione 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 130616, Exp 06/16

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 Locust Avenue, West Long Branch, NJ 07764, UPC 700175760302
Recalling firm
Flawless Beauty LLC
Quantity
unknown
Distribution
Nationwide
Recall date
May 21, 2014
Classification
Class II
Status
Completed
Agency
FDA (drug)
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