Flawless Beauty Recalls Unapproved Laennec Placenta Extract Injections
Flawless Beauty LLC is voluntarily recalling Laennec INJ placenta extract vials because they were marketed without FDA approval.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the product is an unapproved new drug, which fits the rubric criteria for High severity (risk-of-harm products where injury has not yet been reported).
Plain-English summary
Flawless Beauty LLC is voluntarily recalling all lots of Laennec INJ, a placenta extract (human) product sold in 2mL vials. The product was manufactured by GCJBP Corp in Korea and distributed nationwide in the United States. It was sold individually or as part of multi-unit kits.
The recall is being conducted in accordance with a Consent Decree of Permanent Injunction ordered by the United States District Court. The FDA determined that the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), constituting misbranding and an unapproved new drug under the Federal Food, Drug, and Cosmetic Act.
Consumers who have purchased this product should stop using it and contact Flawless Beauty LLC for further instructions.
The recalled product
- Product
- Laennec INJ, Placenta extract (human), 2mL vials, Manufactured by: GCJBP Corp, Korea
- Manufacturer
- Flawless Beauty LLC
- Category
- Drug — Injectable
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Flawless Beauty LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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