PlainRecalls
FDA Drug Moderate Class II Completed

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

Reported: May 21, 2014 Initiated: April 29, 2014 #D-1321-2014

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

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.

Details

Recalling Firm
Flawless Beauty LLC
Units Affected
unknown
Distribution
Nationwide
Location
Asbury Park, NJ

Frequently Asked Questions

What product was recalled?
Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories, UPC 4800573016219. Recalled by Flawless Beauty LLC. Units affected: unknown.
Why was this product recalled?
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 21, 2014. Severity: Moderate. Recall number: D-1321-2014.