Sterilized water for injections BP — Class II drug recall D-0332-2018
Terminated recall by Flawless Beauty LLC, reported 2018-02-14, distributed nationwide. Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different pro
| Recall number | D-0332-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Flawless Beauty LLC, Asbury Park, NJ, United States |
| Recall initiated | 2018-01-19 |
| Classified | 2018-02-05 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2018-09-13 |
| Distributed | Nationwide (US) |
| Reason classes | labeling, unapproved product |
Product
Sterilized water for injections BP, 50 x 5 mL plastic ampules, Manufactured in India
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0332-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.