Drug 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
D-0393-2016
Product summary
- Firm
- Geritrex Corp
- Event
- Event 72509
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,796 jars (8.4 oz) 3,204, (16.9 oz) 3,350
- Official record key
drug-enforcement:D-0393-2016
Official wording
Reason: Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Code information: Lot #: a) 1201092, 1403053, 1210028, 1007059, 1112105, 1305044, 1303079, 1406098, 1407061, 1505037, 1412004 1408081, b) 1112105 & 1007036
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
misbranded