# FDA recall D-1321-2014

> **Flawless Beauty LLC** · Class II · drug recall initiated 2014-04-29.

## 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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1321-2014
- **Recalling firm:** Flawless Beauty LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2014-04-29
- **Report date:** 2014-05-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Asbury Park, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1321-2014

## Citation

> AI Analytics. FDA recall D-1321-2014. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-1321-2014. Source: US FDA. Licensed CC0.

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