The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0331-2018·Announced 2018-02-14

Flawless Beauty Recalls Vitamin C Ampules for Misbranding and Unapproved Status

Flawless Beauty LLC is voluntarily recalling all lots of TP Drug Laboratories Vitamin C ampules nationwide because they were marketed without an approved NDA/ANDA.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source explicitly identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are mapped to a severity score of 4 (Severe).

Plain-English summary

Flawless Beauty LLC is voluntarily recalling all lots of TP Drug Laboratories Vitamin C ampules. The products were sold individually or as part of multi-unit kits and were distributed nationwide in the United States.

The recall is being conducted in accordance with a Consent Decree of Permanent Injunction ordered by the United States District Court. The agency determined that the products were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), constituting misbranding and unapproved new drugs under the Federal Food, Drug, and Cosmetic (FD&C) Act.

Consumers who possess these products should stop using them and follow the instructions provided by the recalling firm or the FDA regarding disposal or return.

The recalled product

Product
TP Drug Laboratories Vitamin C ampules
Manufacturer
Flawless Beauty LLC
Category
Drug — Unapproved New Drug
Hazard

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.

See all 12 products in this recall →

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