Multi-event December 2016 FDA Recall Drug by Gentell, Inc

This Multi-event Class II drug recall was voluntarily initiated by Gentell, Inc on December 15, 2016 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in United States and the recall is currently terminated.

Reported Recall Events

D-0243-2017 TERMINATED D-0242-2017 TERMINATED

Recall Number: D-0243-2017

Reason for Recall
CGMP Deviations
Initiated
12-15-2016
Reported
01-11-2017
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75982
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gentell, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2018
Product Description About Product Description
Full technical description of the product.
Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04

Batch or Lot Expiration Information

Lot# 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

Recall Number: D-0242-2017

Reason for Recall
CGMP Deviations
Initiated
12-15-2016
Reported
01-11-2017
Quantity
3,000 gauzes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75982
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gentell, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2018
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# 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