Ling Zhi capsules

FDA recall notice · announced February 14, 2018 · Flawless Beauty

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Ling Zhi capsules

Reason for recall

Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.

Notes

Distribution: Product was distributed U.S.A. nationwide.
Lot/code information: all lots
Quantity: N/A
Status: Terminated
Products in this recall event:
- TP Drug Laboratories Vitamin C ampules (D-0331-2018)
- Relumins Vitamin C Solvent ampules (D-0325-2018)
- Tationil Glutathione, 600 mg/ 4 mL, polvere e solvente per soluzione iniettabile, Teofarma, s.r.l. (D-0328-2018)
- Relumins Advanced Glutathione kits, 900 mg vials, 1500 mg vials and 3000 mg vials (D-0324-2018)
- Tatiomax Gluatathione Whitening kits, 1400mg vials, Made in Japan (D-0326-2018)
- Laennec INJ, Placenta extract (human), 2mL vials, Manufactured by: GCJBP Corp, Korea (D-0329-2018)
- Reiki Glutathione Whitening kits (D-0330-2018)
- Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm, Roche (D-0327-2018)
- TAD Glutathione Whitening Kits lyophilized powder for injection, 600 mg vials, 10 vials + 10 amps x 4 mL, Manufactured by: Biomedica Foscama Industria, Ferentino, Italy (D-0335-2018)
- Saluta Glutathione Whitening kits, packaged in 600 mg, 1200 mg and 1800 mg glass vials, Manufactured by: Shandong Luye Pharmaceutical Co, Ltd, Yantai, Shandong. PRC (D-0334-2018)
- Sterilized water for injections BP, 50 x 5 mL plastic ampules, Manufactured in India (D-0332-2018)
- Ling Zhi capsules (D-0333-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.