FDA-Drug2015-12-09Class II
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
Geritrex Corp
Hazard
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Sold states
Nationwide
Affected count
3,796 jars (8.4 oz) 3,204, (16.9 oz) 3,350
Manufactured in
144 Kingsbridge Road East, Mount Vernon, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0393-2016Don't want to check this manually?
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