FDA recall D-0886-2019

King Bio Inc. · Class I · drug

Product

Dr. King's SafeCare Rx GynePlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955000723, NDC 57955-0007-2

Reason for recall

Microbial contamination

Distribution

U.S.A. Nationwide, Canada, and Australia.

Key facts

Status
Terminated
Initiation date
2018-07-20
Report date
2019-03-20
Termination date
2022-01-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Asheville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0886-2019