The Recall Desk
ModerateFDA (Drugs)·D-1316-2014·Announced 2014-05-21

Flawless Beauty LLC Recalls Laroscorbine Platinium Injectable Solution

Flawless Beauty LLC is recalling Laroscorbine Platinium injectable solution because it was marketed without an approved NDA/ANDA and includes drug claims to act as an antidote.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The primary issue is regulatory (unapproved marketing and labeling claims) rather than a confirmed high-risk pathogen or structural defect causing immediate severe injury.

Plain-English summary

Flawless Beauty LLC is recalling Laroscorbine Platinium (vitamin C/collagen) injectable I.V. solution, 1 gm/0.35 gm, 5 mL ampoules. The product is packaged in 10-count ampoules per box and is identified by Lot # F040 with an expiration date of 08/16. The recall is nationwide.

The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product is sold over the counter with labeling that includes drug claims to act as an antidote.

Consumers who have purchased this product should stop using it and contact Flawless Beauty LLC for further instructions or a refund.

The recalled product

Product
Laroscorbine Platinium (vitamin C/collagen) injectable I.V. solution, 1 gm/0.35 gm, 5 mL ampoules, packaged in 10-count ampoules per box, Laboratories Roche Nicholas S.A., F-74240 Gaillard, - Tel.: 04 50 87 70 70, Fabricant : Produits Roche, 52, Bld du Parc, 92521 Neulilly -sur-S

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 (2)

  • Lot #: F040
  • Exp 08/16

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 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.

See all 6 products in this recall →