Polyethylene Glycol 3350-GRX Powder 100% jars a) recalled over labeling errors

Recall date

October 27, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Geritrex Corp recalls 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 541…

Recall number

D-0393-2016

FDA classification

Class II

Brand / firm

Geritrex Corp

Sold / distributed

Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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