(RxWiki News) More companies are under fire for selling unapproved umbilical cord products.
The US Food and Drug Administration (FDA) has issued a warning to California-based companies Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC for producing and offering unapproved products made from umbilical cord blood.
According to the FDA, these companies have not been following the necessary manufacturing requirements when making the products in question. The FDA said these unapproved products may place consumers at risk.
The products listed in the FDA’s recent warning were PURE and PURE PRO.
In addition to sending letters to Liveyon Labs Inc. and Liveyon LLC, the FDA sent letters to companies for distributing unapproved stem cell products. These companies included RichSource Stem Cells, Inc., and Chara Biologics, Inc. Furthermore, the FDA sent another 20 letters to companies and health care providers for offering unapproved stem cell products.
Here’s what the FDA found in its inspection of these products:
- The companies were making products for people who were unrelated to the donors of the products.
- The companies did not have the licenses or applications necessary to market these products.
- The companies were not following the required manufacturing process to ensure the products were not contaminated.
The FDA urged consumers to report any adverse events tied to products made by any of these companies, as well as other stem cell treatments. These adverse events can be reported to the FDA’s MedWatch Adverse Event Reporting program.
Ask your health care provider any questions you have about these or similar products.
Written by Anyssa Garza, PharmD, BCMAS