FDA recall D-0393-2016

Product

Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 g) (NDC 54162-335-02), b) Net wt. 16.9 oz (500 g) (NDC 54162-335-05), Distributed by: Geritrex Corporation, Mount Vernon, NY 10550

Reason for recall

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-10-27

Report date

2015-12-09

Termination date

2018-06-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mount Vernon, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0393-2016