Drug product
Teething Drops, Homeopathic Drops for Temporary Relief of Pain Caused by Teething, 1 Fl Ounce glass amber bottle with glass dropper, MBi Nutraceuticals, Lindon, UT 84042. Bar Code: 3 58301 04011 0
D-0867-2018
Product summary
- Event
- Event 80119
- Status
- Terminated
- Classification
- Class II
- Quantity
- 121 bottles
- Official record key
drug-enforcement:D-0867-2018
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: 15041402, No EXP date
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls