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

D-0870-2018

May 15, 2018

Class II

Product summary

Firm: MBi Distributing Inc. dba MBi Nutraceuticals
Event: Event 80119
Status: Terminated
Classification: Class II
Quantity: 343 bottles
Official record key: drug-enforcement:D-0870-2018

Official wording

Reason: 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.

Code information: Lot: 14093001, EXP 09/2020

Distribution pattern: Nationwide in the USA

Derived failure modes

Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

Lack of Processing Controls