FDA recall D-0329-2018

Product

Laennec INJ, Placenta extract (human), 2mL vials, Manufactured by: GCJBP Corp, Korea

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.

Distribution

Product was distributed U.S.A. nationwide.

Key facts

Status

Terminated

Initiation date

2018-01-19

Report date

2018-02-14

Termination date

2018-09-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Asbury Park, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0329-2018