- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Reason for Announcement:
Recall Reason DescriptionLack of Adequate Controls
- Company Name:
- MBI Distributing, Inc.
- Brand Name:
Brand Name(s)MBI Distributing, Inc.
- Product Description:
Product DescriptionVarious Homeopathic Products
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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company Contact Information
- Michelle Jensen