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Class II: temporary or reversible health riskTerminated

MBi Distributing Inc. dba MBi Nutraceuticals Nausea Drops Recall

Nausea Drops, Homeopathic Drops for Temporary Relief of Motion Sickness, Morning Sickne…

MBi Distributing Inc. dba MBi Nutraceuticals · Lindon, UT

Risk level
Class II
Reported by FDA
Jun 20, 2018
Recall ID
D-0868-2018
Check your lot numberHow we source this data

Summary

MBi Distributing Inc. dba MBi Nutraceuticals recalled Nausea Drops starting May 15, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0868-2018 on Jun 20, 2018. 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. Status: Terminated.

Why it was recalled

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.

Product description

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

Lot numbers, UPCs & expiration codes

Lot: 17011201, No EXP Date

Where it was sold

Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0868-2018
Classification
Class II
Status
Terminated
Recall initiated
May 15, 2018
FDA report date
Jun 20, 2018
Quantity
48 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
MBi Distributing Inc. dba MBi Nutraceuticals

Original FDA data

Every field from FDA enforcement report D-0868-2018, exactly as published.

Show all FDA fields
City
Lindon
State
UT
Status
Terminated
Country
United States
Event ID
80119
Address
211 N 1800 W
Code information
Lot: 17011201, No EXP Date
Postal code
84042-1627
Report date
Jun 20, 2018
Product type
Drugs
Recall number
D-0868-2018
Classification
Class II
Recalling firm
MBi Distributing Inc. dba MBi Nutraceuticals
Product quantity
48 bottles
Termination date
Jan 23, 2020
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.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Nationwide in the USA
Recall initiation date
May 15, 2018
Initial firm notification
Press Release
Center classification date
Jun 14, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0868-2018, published Jun 20, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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