Drug product
Intestinal Colic Drops, Homeopathic Drops for Temporary Relief of Flatulent Colic, 1 ounce amber glass bottle with glass dropper, liquid, Meteorism, and Porphyrinuria. MBi Nutraceuticals Lindon, UT 84042
D-0869-2018
Product summary
- Event
- Event 80119
- Status
- Terminated
- Classification
- Class II
- Quantity
- 78 bottles
- Official record key
drug-enforcement:D-0869-2018
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: 8040802, EXP 04/2021.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls