Safety

Company Announcement

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

MBI Distributing, Inc. Issues Voluntary Nationwide Recall of Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir Due to a Lack of Process Controls

For Immediate Release

May 18, 2018

Contact

Consumers

Michelle Jensen
801-796-8745

Announcement

MBI Distributing, Inc. 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, to the consumer level. The drug products have been found to be manufactured with a lack of adequate controls.

Risk Statement: Manufacturing products without proper process controls increases the probability that products will vary in strength, quality and purity.  Use of these products could result in an adverse reaction, especially in vulnerable populations such as infants and children. To date, MBI Distributing, Inc. has not received any reports of adverse events related to this recall.

These homeopathic drug products are in liquid oral dosage form and are packaged in sizes from 1 fluid ounce to 8 fluid ounces.

Product/Brand Name Size UPC Code
Teething Drops 1 Fluid Ounce 58301-04011
Nausea Drops 1 Fluid Ounce 58301-05711
Intestinal Colic Drops

 

1 Fluid Ounce 58301-04211
Stomach Calm 8 Fluid Ounces 58301-38414
Expectorant Cough Syrup 8 Fluid Ounces 58301-08214
Argentum Elixir 8 Fluid Ounces 58301-18114
Silver/Zinc Throat Spray 4 Fluid Ounces 58301-18118

These products were distributed nationwide to health care professionals, retail stores, and consumers.

MBI Distributing, Inc. is notifying its distributors and retailers by mail and is arranging for return of all recalled drug products in their possession. Consumers who have recalled product in their possession should stop using and discard the recalled product.

Consumers with questions regarding this recall can contact MBI Distributing, Inc. by calling 801-796-8745 (Monday-Friday 9:00 am-5:00 pm Mountain Time). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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Page Last Updated: 05/18/2018
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