Home / Recalls / Flawless Beauty LLC / D-1319-2014

D-1319-2014 Class II

Recalled by Flawless Beauty LLC — Asbury Park, NJ

Recall Details

Product Type
Drugs
Report Date
May 21, 2014
Initiation Date
April 29, 2014
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
unknown

Product Description

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

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.

Distribution Pattern

Nationwide

Code Information

Lot #: 130616, Exp 06/16

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  • D-0331-2018 Class II — TP Drug Laboratories Vitamin C ampules (January 19, 2018)
  • D-0327-2018 Class II — Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm, Roche (January 19, 2018)
  • D-0326-2018 Class II — Tatiomax Gluatathione Whitening kits, 1400mg vials, Made in Japan (January 19, 2018)
  • D-0335-2018 Class II — TAD Glutathione Whitening Kits lyophilized powder for injection, 600 mg vials, 1 (January 19, 2018)
  • D-0329-2018 Class II — Laennec INJ, Placenta extract (human), 2mL vials, Manufactured by: GCJBP Corp, K (January 19, 2018)
  • D-0325-2018 Class II — Relumins Vitamin C Solvent ampules (January 19, 2018)
  • D-0324-2018 Class II — Relumins Advanced Glutathione kits, 900 mg vials, 1500 mg vials and 3000 mg vial (January 19, 2018)
  • D-0328-2018 Class II — Tationil Glutathione, 600 mg/ 4 mL, polvere e solvente per soluzione iniettabile (January 19, 2018)
  • D-0334-2018 Class II — Saluta Glutathione Whitening kits, packaged in 600 mg, 1200 mg and 1800 mg glas (January 19, 2018)