FDA recall D-0773-2023

Product

Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.

Reason for recall

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

Distribution

Product was distributed Nationwide.

Key facts

Status

Ongoing

Initiation date

2023-05-03

Report date

2023-06-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lincoln, RI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0773-2023