FDA Drug recall D-0393-2016
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), Distribu…
- FDA Drug
- Class II
- terminated
- Published 2015-12-09
On 2015-12-09 the FDA classified a Class II recall of 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), Distribu… by Geritrex, citing marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0393-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-27 |
| Published | 2015-12-09 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Geritrex |
| Distribution | US |
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
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Identifiers
| code_info | Lot #: a) 1201092, 1403053, 1210028, 1007059, 1112105, 1305044, 1303079, 1406098, 1407061, 1505037, 1412004 1408081, b) 1112105 & 1007036 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0393-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.