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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72509

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 27, 2015
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Geritrex Corp

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 4

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 only, Distributed by Geritrex Corporation, East Mount Vernon, NY 10550

D-0390-2016
Recall number
D-0390-2016
Initiated
October 27, 2015
Classification
Class II
Status
Terminated
Recalling firm
Geritrex Corp
Quantity
9,948 tubes: 3 oz(8,832), 7 oz(1,116)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
misbranded

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

Code information

Lot #: a)1502156, 1507104 b)1503039, 1507001

Distribution pattern

Nationwide

drug · product 2 of 4

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 Vernon, NY 10550, NDC 54162-016-15

D-0391-2016
Recall number
D-0391-2016
Initiated
October 27, 2015
Classification
Class II
Status
Terminated
Recalling firm
Geritrex Corp
Quantity
1,032 tubes

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
misbranded

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

Code information

Lot # 1502078, 1504139

Distribution pattern

Nationwide

drug · product 3 of 4

GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx only, Distributed by Geritrex Corporation Mount Vernon, NY 10550, NDC 54162-015-12

D-0392-2016
Recall number
D-0392-2016
Initiated
October 27, 2015
Classification
Class II
Status
Terminated
Recalling firm
Geritrex Corp
Quantity
844,704 suppositories

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
misbranded

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

Code information

Lot #: 1310001, 13J04, 1310167, 1311013, 1312008, 1401055, 13S02, 14A05, 1402061, 14C01, 14C05, 14C06, 14E02, 1405081, 1406107, 1407062, 14096751, 14096752, 14096753, 15026752, 15026752, 15046752, 15066752, 15066753

Distribution pattern

Nationwide

drug · product 4 of 4

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
Recall number
D-0393-2016
Initiated
October 27, 2015
Classification
Class II
Status
Terminated
Recalling firm
Geritrex Corp
Quantity
3,796 jars (8.4 oz) 3,204, (16.9 oz) 3,350

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
misbranded

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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