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Class II: temporary or reversible health riskCompleted

Flawless Beauty Sterile Water for Injection Recall

Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manu…

Flawless Beauty LLC · Asbury Park, NJ

Risk level
Class II
Reported by FDA
May 21, 2014
Recall ID
D-1321-2014
Check your lot numberHow we source this data

Summary

Flawless Beauty recalled Sterile Water for Injection starting Apr 29, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1321-2014 on May 21, 2014. Reason: Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection. Status: Completed.

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.

Product description

Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories, UPC 4800573016219

Lot numbers, UPCs & expiration codes

Lot #: 16U394, Exp 04/16; 16U421, Exp 08/16; 16U423, Exp 09/16

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1321-2014
Classification
Class II
Status
Completed
Recall initiated
Apr 29, 2014
FDA report date
May 21, 2014
Quantity
unknown
Recall type
Voluntary: Firm initiated
Recalling firm
Flawless Beauty LLC

Original FDA data

Every field from FDA enforcement report D-1321-2014, exactly as published.

Show all FDA fields
City
Asbury Park
State
NJ
Status
Completed
Country
United States
Event ID
68158
Address
1215 Main St
Code information
Lot #: 16U394, Exp 04/16; 16U421, Exp 08/16; 16U423, Exp 09/16
Postal code
07712-5940
Report date
May 21, 2014
Product type
Drugs
Recall number
D-1321-2014
Classification
Class II
Recalling firm
Flawless Beauty LLC
Product quantity
unknown
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.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories, UPC 4800573016219
Distribution pattern
Nationwide
Recall initiation date
Apr 29, 2014
Initial firm notification
Press Release
Center classification date
May 13, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1321-2014, published May 21, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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