Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing: Recall—due to a lack of adequate controls
FDA May 23, 2018
Audience
Consumer, health professional, pharmacy
Issue
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.
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.
Background
These homeopathic drug products are in liquid oral dosage form and are packaged in sizes from 1 fluid ounce to 8 fluid ounces.
Recommendation
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 a.m.-5:00 p.m. Mountain Time). Consumers should contact their physician or health-care provider if they have experienced any problems that may be related to taking or using these drug products.
-
Exclusive Write-ups & Webinars by KOLs
-
Daily Quiz by specialty
-
Paid Market Research Surveys
-
Case discussions, News & Journals' summaries