Reported May 21, 2014 · Completed
Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by:…
Flawless Beauty LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Flawless Beauty LLC · 1215 Main St · Asbury Park, NJ · 07712-5940
Is this the product you have?
Sterile Water for Injection5 mL ampoulespackaged in 50-count ampoules per box
- Manufactured and Distributed byEuro Med Laboratories, UPC 4800573016219
- Lot codes and dates
Lot #: 16U394Exp 04/1616U421Exp 08/1616U423Exp 09/16
- Amount recalled
- unknown
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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