FDA recall D-0873-2018

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

Product

Silver-Zinc Throat Spray, HOMEOPATHIC IMMUNE DEFENSE, 50PPM, 4oz/50 ppm/ 120ml,amber PET bottle with white sprayer. MBi Nutraceuticals Lindon, Utah 84042 USA. Bar Code: 3 58301 18118 9

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-0873-2018