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Recall Observatory FDA recall evidence

Drug product

Teething Drops, Homeopathic Drops for Temporary Relief of Pain Caused by Teething, 1 Fl Ounce glass amber bottle with glass dropper, MBi Nutraceuticals, Lindon, UT 84042. Bar Code: 3 58301 04011 0

D-0867-2018

May 15, 2018

Class II

Product summary

Firm
MBi Distributing Inc. dba MBi Nutraceuticals
Event
Event 80119
Status
Terminated
Classification
Class II
Quantity
121 bottles
Official record key
drug-enforcement:D-0867-2018

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: 15041402, No EXP date

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Lack of Processing Controls