Recalls / Class II
Class IID-0871-2018
Product
Expectorant Cough Syrup, Homeopathic Syrup for Temporary Relief of Cough & Bronchitis. 8 Fl Ounces amber PET bottle with black cap. MBi Nutraceuticals 211 N 1800 W, Lindon, UT 84042. Bar Code: 3 58301 08214 1
- Affected lot / code info
- Lot numbers: 16081901, EXP: 08/2018: 17031604, EXP: 03/2019; 17110901, EXP: 11/2019
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
- 1,971 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-0871-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.