Drug product

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

D-1321-2014

April 29, 2014

Class II

Product summary

Firm: Flawless Beauty LLC
Event: Event 68158
Status: Completed
Classification: Class II
Quantity: unknown
Official record key: drug-enforcement:D-1321-2014

Official wording

Reason: Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection.

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

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection.