Recalls / Class II
Class IID-0868-2018
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
- Affected lot / code info
- Lot: 17011201, No EXP Date
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.
Recalling firm
- Firm
- MBi Distributing Inc. dba MBi Nutraceuticals
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 211 N 1800 W, N/A, Lindon, Utah 84042-1627
Distribution
- Quantity
- 48 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-05-15
- FDA classified
- 2018-06-14
- Posted by FDA
- 2018-06-20
- Terminated
- 2020-01-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0868-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.