FDA recall D-0242-2017

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

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-0242-2017