Exact FDA event identifier

Event 71441

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: June 05, 2015
Product types: Drug
Classifications: Class III
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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 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 1

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 Corporation, Mount Vernon, NY 10550

D-1238-2015

Recall number: D-1238-2015
Initiated: June 05, 2015
Classification: Class III
Status: Terminated
Recalling firm: Geritrex Corp
Quantity: 1,488 tubes (1,008 3 oz. tubes and 480 7 oz. tubes)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviation

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviation: Poor container closure of the bulk storage container

Code information

a) Lot # 1502076; Exp. 08/16 b) Lot # 1502077,1503030; Exp. 08/16

Distribution pattern

Nationwide