FDA recall D-0243-2017
Gentell, Inc · Class II · drug
Product
Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04
Reason for recall
CGMP Deviations
Distribution
United States
Key facts
- Status
- Terminated
- Initiation date
- 2016-12-15
- Report date
- 2017-01-11
- Termination date
- 2018-02-16
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Bristol, PA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0243-2017