Drug 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
D-0871-2018
Product summary
- Event
- Event 80119
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,971 bottles
- Official record key
drug-enforcement:D-0871-2018
Official wording
Reason: 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.
Code information: Lot numbers: 16081901, EXP: 08/2018: 17031604, EXP: 03/2019; 17110901, EXP: 11/2019
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls