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
Gentell2701 BristolPA 19007NDC 61554-111-04
- Lot codes and dates
- 4 oz
- tube
Gen Code 11240 Lot #: 112161511217131122215112331511252151126515112731511300151133615113161511362151136415110061611026161105516110621611068161108816110961611103161111816111411611166161118716111951611215161123116Exp. 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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