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Class II: temporary or reversible health riskTerminated

MBi Distributing Inc. dba MBi Nutraceuticals Silver-Zinc Throat Spray Recall

Silver-Zinc Throat Spray, HOMEOPATHIC IMMUNE DEFENSE, 50PPM, 4oz/50 ppm/ 120ml,amber PE…

MBi Distributing Inc. dba MBi Nutraceuticals · Lindon, UT

Risk level
Class II
Reported by FDA
Jun 20, 2018
Recall ID
D-0873-2018
Check your lot numberHow we source this data

Summary

MBi Distributing Inc. dba MBi Nutraceuticals recalled Silver-Zinc Throat Spray starting May 15, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0873-2018 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

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

Lot numbers, UPCs & expiration codes

Lot: 15050801, EXP 05/2018

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-0873-2018
Classification
Class II
Status
Terminated
Recall initiated
May 15, 2018
FDA report date
Jun 20, 2018
Quantity
134 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
MBi Distributing Inc. dba MBi Nutraceuticals

Original FDA data

Every field from FDA enforcement report D-0873-2018, 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: 15050801, EXP 05/2018
Postal code
84042-1627
Report date
Jun 20, 2018
Product type
Drugs
Recall number
D-0873-2018
Classification
Class II
Recalling firm
MBi Distributing Inc. dba MBi Nutraceuticals
Product quantity
134 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
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
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-0873-2018, published Jun 20, 2018. View the source record (openFDA) · FDA enforcement reports

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

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