Generic drug makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Geritrex with 15 drug recalls and 4 510(k) clearances. The most recent is a drug recall dated Oct 27, 2015: GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx only, Distr….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 27, 2015 | GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx only, Distributed by Geritrex Corporation Mount Vernon, NY 105Class II · Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. | Drug recalls |
| Oct 27, 2015 | Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz (200 g) (NDC 54162-640-07), Rx Only For topical use onClass II · Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. | Drug recalls |
| Oct 27, 2015 | 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), DistribClass II · Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. | Drug recalls |
| Oct 27, 2015 | Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topical use only, Distributed byGeritrex Corporation 144, Mount VernClass II · Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. | Drug recalls |
| Jun 5, 2015 | Carb-O-Philic 40 Cream, 40%, a) 3 oz. tube (NDC 54162-640-03) b) 7 oz. tube (NDC 54162-640-07), Rx Only, Manufactured by Geritrex CorporatioClass III · CGMP Deviation: Poor container closure of the bulk storage container | Drug recalls |
| Apr 3, 1995 | GRX FOAM DRESSINGK945224 · KMF | 510(k) clearances |
| Sep 22, 1994 | GERITREX STERILE SALINE SOLUTION FOR IRRIGATIONK931509 · JOL | 510(k) clearances |
| Feb 14, 1994 | GERITREX STERILE WATER FOR IRRIGATIONK931511 · JOL | 510(k) clearances |
| Jul 13, 1993 | GERITREX STERILE SALINE WET DRESSINGK931510 · FRO | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
