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Recall Observatory FDA recall evidence

Drug product

Expectorant Cough Syrup, Homeopathic Syrup for Temporary Relief of Cough & Bronchitis. 8 Fl Ounces amber PET bottle with black cap. MBi Nutraceuticals 211 N 1800 W, Lindon, UT 84042. Bar Code: 3 58301 08214 1

D-0871-2018

May 15, 2018

Class II

Product summary

Firm
MBi Distributing Inc. dba MBi Nutraceuticals
Event
Event 80119
Status
Terminated
Classification
Class II
Quantity
1,971 bottles
Official record key
drug-enforcement:D-0871-2018

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 numbers: 16081901, EXP: 08/2018: 17031604, EXP: 03/2019; 17110901, EXP: 11/2019

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Lack of Processing Controls