FDA recall D-1321-2014

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

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

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