Laennec INJ recalled over labeling errors

Recall date

January 19, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

D-0329-2018

FDA classification

Class II

Brand / firm

Flawless Beauty LLC

Sold / distributed

Product was distributed U.S.A. nationwide.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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