FDA Drug recall D-1321-2014
Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories,…
- FDA Drug
- Class II
- completed
- Published 2014-05-21
On 2014-05-21 the FDA classified a Class II recall of Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories,… by Flawless Beauty, citing marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1321-2014 |
| Classification | Class II |
| Status | completed |
| Initiated | 2014-04-29 |
| Published | 2014-05-21 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Flawless Beauty |
| Distribution | US |
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
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection.
Identifiers
| upc | 4800573016219 |
|---|---|
| code_info | Lot #: 16U394, Exp 04/16; 16U421, Exp 08/16; 16U423, Exp 09/16 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1321-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.