Sterile Water for Injection — Class II drug recall D-1321-2014
Completed recall by Flawless Beauty LLC, reported 2014-05-21, distributed nationwide. Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be u
| Recall number | D-1321-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Flawless Beauty LLC, Asbury Park, NJ, United States |
| Recall initiated | 2014-04-29 |
| Classified | 2014-05-13 |
| Reported by FDA | 2014-05-21 |
| Distributed | Nationwide (US) |
| Reason classes | labeling, unapproved product |
| UPC / GTIN / UDI-DI | 04800573016219 |
| Lot numbers | 04/16, 08/16, 09/16, 16U394, 16U421, 16U423 |
Product
Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories, UPC 4800573016219
Reason for recall
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection.
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-1321-2014. 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.