Gentell Hydrogel Wound Dressing REGULAR recalled over manufacturing violations
- Recall date
- December 15, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Gentell, Inc recalls Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04
- Recall number
- D-0243-2017
- FDA classification
- Class II
- Brand / firm
- Gentell, Inc
- Sold / distributed
- United States
Why it was recalled
CGMP Deviations
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04
Get recall alerts
Free email alert whenever Gentell, Inc has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Gentell, Inc