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.
Recall initiated: 20151027
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated