Reported Jan 11, 2017 · Terminated

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

Gentell, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Gentell, Inc · 2701 Bartram Rd · Bristol, PA · 19007-6810

Is this the product you have?

  • Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube
  • Manufactured by
    • Gentell
    • 2701 Bristol
    • PA 19007
    • NDC 61554-111-04
Lot codes and dates
  • 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
Amount recalled
unknown

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Why it was recalled

CGMP Deviations

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Feb 16, 2018 · Data as of Sep 19, 7:09 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.