FDA recall D-0686-2019

King Bio Inc. · Class I · drug

Product

Dr. King's SafeCare Rx Newborn Tonic Children High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806 USA, UPC 357955011422, NDC 57955-0114-2

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-0686-2019