Flawless Beauty Recalls Sterilized Water for Injections Due to Misbranding
Flawless Beauty LLC is voluntarily recalling all lots of sterilized water for injections sold in the U.S. because the products were marketed without FDA approval.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the products are unapproved new drugs marketed without NDA/ANDA approval.
Plain-English summary
Flawless Beauty LLC is voluntarily recalling all lots of sterilized water for injections BP, 50 x 5 mL plastic ampules, manufactured in India. The product was distributed nationwide in the United States, either 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 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 Act.
Consumers who possess these products should stop using them and contact the recalling firm for further instructions. The recall covers all lots of the affected products.
The recalled product
- Product
- Sterilized water for injections BP, 50 x 5 mL plastic ampules, Manufactured in India
- Manufacturer
- Flawless Beauty LLC
- Category
- Drug — Unapproved New Drug
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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