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 54
Recalled December 9, 2015 · FDA recall D-0393-2016 · Geritrex
Hazard
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. · FDA Class II
Units
3,796 jars (8.4 oz) 3,204, (16.9 oz) 3,350
Sold at
Nationwide
Description
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
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
Manufacturer(s)
Geritrex Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →