Home / Recalls / Gentell, Inc / D-0242-2017

D-0242-2017 Class II Terminated

Recalled by Gentell, Inc — Bristol, PA

FDA drug recall D-0242-2017 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). Affected quantity: 3,000 gauzes.

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 Quantity: 3,000 gauzes

Product description

Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufactured by: Gentell, 2701 Bartram Road, Bristol, PA 19007

Reason for recall

CGMP Deviations

Distribution pattern

United States

Code information

Gentell Hydrogel AG 2X2 (Gen-11260) Lot #: 1121615, 1121713, 1122215; Exp. 11/18 Gentell Hydrogel AG 4X4 (Gen-11460) Lot #: 1123315, 1125215, 1126515; Exp. 11/18 Gentell Hydrogel AG 4X8 (Gen-11860) Lot #: 1127315, 1130015, 1133615; 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-0242-2017
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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