FDA recall D-0869-2018

MBi Distributing Inc. dba MBi Nutraceuticals · Class II · drug

Product

Intestinal Colic Drops, Homeopathic Drops for Temporary Relief of Flatulent Colic, 1 ounce amber glass bottle with glass dropper, liquid, Meteorism, and Porphyrinuria. MBi Nutraceuticals Lindon, UT 84042

Reason for recall

Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2018-05-15
Report date: 2018-06-20
Termination date: 2020-01-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lindon, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0869-2018