The Recall Desk

FDA (Drugs) recall action 68158

Flawless Beauty LLC recalled 6 products on 2014-05-21

The FDA (Drugs) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2014-05-21
Critical
0
Units
—

Why these products were recalled

Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.

Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.

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

The agency’s own wording, quoted from the enforcement report.

1–6 of 6

  • SevereFDA (Drugs)··2014-05-21

    FDA Recalls Unapproved Saluta Reduced Glutathione Injection Powder

    Flawless Beauty LLC is recalling Saluta (reduced glutathione) Powder for Injection because it was marketed without an approved NDA/ANDA and is labeled for use as an antidote.

    Product
    Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 10 vials per box, Exclusively Distributed by: QAF Pharmaceuticals Inc. Philippines, Unit Unit 202 ECG Building, Multinational Avenue, Multinational Village, Parahaque City, Metro Manila Philippines; Manuf
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2014-05-21

    Flawless Beauty Recalls Tatiomax Injection Vials Sold Without FDA Approval

    Flawless Beauty LLC is recalling Tatiomax powder for injection vials because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Tatiomax (reduced glutathione/hydrolyzed collagen) powder for injection vials, 1200 mg/200 mg, 10-count vials per box, Manufactured by: Sujie Pharmaceutical Ltd., Tokyo, Japan, UPC 4973430081576
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2014-05-21

    Flawless Beauty Recalls Sterile Water for Injection Sold Without Approval

    Flawless Beauty LLC is recalling Sterile Water for Injection ampoules sold over the counter without an approved NDA or ANDA.

    Product
    Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories, UPC 4800573016219
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··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.

    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
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2014-05-21

    Flawless Beauty LLC Recalls Laroscorbine Platinium Injectable Solution

    Flawless Beauty LLC is recalling Laroscorbine Platinium injectable solution because it was marketed without an approved NDA/ANDA and includes drug claims to act as an antidote.

    Product
    Laroscorbine Platinium (vitamin C/collagen) injectable I.V. solution, 1 gm/0.35 gm, 5 mL ampoules, packaged in 10-count ampoules per box, Laboratories Roche Nicholas S.A., F-74240 Gaillard, - Tel.: 04 50 87 70 70, Fabricant : Produits Roche, 52, Bld du Parc, 92521 Neulilly -sur-S
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2014-05-21

    Flawless Beauty Recalls Vitamin C Injection Sold Without FDA Approval

    Flawless Beauty LLC is recalling Vitamin C Injection ampoules marketed without an approved NDA/ANDA. The product is sold over the counter with labeling indicating disease treatment.

    Product
    Vitamin C (ascorbic acid) Injection, USP, 500 mg per 2 mL, 50 x 2 mL ampoules per box, Manufactured by: TP Drug Laboratories (1969) Co., Ltd., 98 Soi Sukhumvlt 62, Yak 1, Bangchak, Prakanong, Bangkok 10260, Thailand, Reg. No. 1 A 1557/30; UPC 8 853533 000533
    Category
    Distribution
    0 states