FDA recall D-0870-2018

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

Product

Stomach Calm, Calms Upset Stomach and Aids in Treatment of Simple Diarrhea, 8 fl. oz., liquid 8 ounce amber PET bottle with Black CRC Cap, MBi Nutraceuticals Lindon, UT 84042. Bar Code: 3 58301 38414 2

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-0870-2018