Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 g) (NDC 54162-335-02), b) Net wt. 1...
FDA Recall #D-0393-2016 — Class II — October 27, 2015
Product Description
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.
Recalling Firm
Geritrex Corp — Mount Vernon, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3,796 jars (8.4 oz) 3,204, (16.9 oz) 3,350
Distribution
Nationwide
Code Information
Lot #: a) 1201092, 1403053, 1210028, 1007059, 1112105, 1305044, 1303079, 1406098, 1407061, 1505037, 1412004 1408081, b) 1112105 & 1007036
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated