MBi Nutraceuticals Recalls Homeopathic Nausea Drops Due to Manufacturing Controls
MBi Nutraceuticals is voluntarily recalling Nausea Drops and other homeopathic products due to a lack of adequate manufacturing controls.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and is a voluntary precautionary recall due to a lack of manufacturing controls, with no specific reported illnesses or injuries mentioned in the source text.
Plain-English summary
MBi Distributing Inc. dba MBi Nutraceuticals is voluntarily recalling all lots of several homeopathic products, including Nausea Drops, Teething Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir. The recall covers products within their expiration dates.
The recall was initiated because the firm identified a lack of adequate controls during the manufacturing process. The specific product details for the Nausea Drops include a 1 Fl. Ounce amber glass bottle with a glass dropper, manufactured in Lindon, UT. The distribution pattern for the recalled items is nationwide in the USA.
Consumers who have purchased these products should stop using them and contact the recalling firm for further instructions or a refund. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 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
- Manufacturer
- MBi Distributing Inc. dba MBi Nutraceuticals
- Category
- Drug — Homeopathic
- Hazard
- Affected units
- 48
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 17011201
- No EXP Date
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by MBi Distributing Inc. dba MBi Nutraceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · MBi Distributing Inc. dba MBi Nutraceuticals
See all →- ModerateMBi Homeopathic Teething Drops Recalled for Lack of Manufacturing Controls
FDA (Drugs) · 2018-06-20
- ModerateMBi Recalls Homeopathic Products Due to Manufacturing Control Deficiencies
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- ModerateMBi Nutraceuticals Recalls Stomach Calm and Other Homeopathic Products
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FDA (Drugs) · 2018-06-20
- ModerateMBi Nutraceuticals Recalls Homeopathic Drops Due to Manufacturing Control Deficiencies
FDA (Drugs) · 2018-06-20
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