Drug recall: Teething Drops, Homeopathic Drops for Temporary Relief of Pain Caused by Teething, 1 Fl Ounce glass amber bottle with…
Class II FDA enforcement event 80119. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
MBi Distributing Inc. dba MBi Nutraceuticals started this drug recall on 15 May 2018. The firm address in the FDA record is in Lindon, UT. FDA put the recall in Class II. FDA event 80119 has 7 product records. The first FDA enforcement report date is 20 Jun 2018. The record gives the status Terminated, with the termination date 23 Jan 2020.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide in the USA
Recalling firm
MBi Distributing Inc. dba MBi Nutraceuticals, Lindon, UT.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
7 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0867-2018 | 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 | 121 bottles | Class II | Terminated | 20 Jun 2018 |
| D-0868-2018 | Nausea Drops, Homeopathic Drops for Temporary Relief of Motion Sickness, Morning Sickness, and General Nausea, 1 Fl. Ounce amber glass bottle with glass dropper. MBi Nutraceuticals Lindon, UT 84042. Bar Code: 1 58301 04711 4 | 48 bottles | Class II | Terminated | 20 Jun 2018 |
| D-0869-2018 | Intestinal Colic Drops, Homeopathic Drops for Temporary Relief of Flatulent Colic, 1 ounce amber glass bottle with glass dropper, liquid, Meteorism, and Porphyrinuria. MBi Nutraceuticals Lindon, UT 84042 | 78 bottles | Class II | Terminated | 20 Jun 2018 |
| D-0870-2018 | 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 | 343 bottles | Class II | Terminated | 20 Jun 2018 |
| D-0871-2018 | 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 | 1,971 bottles | Class II | Terminated | 20 Jun 2018 |
| D-0872-2018 | Argentum Elixir Colloidal Silver, 50 PPM Homeopathic Infection Fighter, 8 fl oz. amber PET bottle with white sprayer. MBi nutraceuticals Lindon UT, 84042. Bar COde: 3 58301 18114 1 | 1,688 bottles | Class II | Terminated | 20 Jun 2018 |
| D-0873-2018 | 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 | 134 bottles | Class II | Terminated | 20 Jun 2018 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2018
- 367
- Share of these events in Class II
- 60%
- Product records in this event
- 7
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report D-0867-2018The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 80119. https://recallregister.com/fda/ii/80119/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide in the USA
- What quantity of product is in FDA event 80119?
- The event has 7 product records. The first record gives this quantity:
121 bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2018 have the same class?
- 60% of the 367 drug events that started in 2018 are in Class II.