Home / Recalls / Gentell, Inc / D-0243-2017

D-0243-2017 Class II Terminated

Recalled by Gentell, Inc — Bristol, PA

FDA drug recall D-0243-2017 was initiated by Gentell, Inc on Dec 15, 2016 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated Feb 16, 2018).

Recall details

Product Type: Drugs
Report Date: Jan 11, 2017
Initiation Date: Dec 15, 2016
Termination Date: Feb 16, 2018
Voluntary/Mandated: Voluntary: Firm initiated

Product description

Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04

Reason for recall

CGMP Deviations

Distribution pattern

United States

Code information

4 oz. tube: Gen Code 11240 Lot #: 1121615, 1121713, 1122215, 1123315, 1125215, 1126515, 1127315, 1130015, 1133615, 1131615, 1136215, 1136415, 1100616, 1102616, 1105516, 1106216, 1106816, 1108816, 1109616, 1110316, 1111816, 1114116, 1116616, 1118716, 1119516, 1121516, 1123116; Exp. 11/18

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0243-2017
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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