Drug product
Silver-Zinc Throat Spray, HOMEOPATHIC IMMUNE DEFENSE, 50PPM, 4oz/50 ppm/ 120ml,amber PET bottle with white sprayer. MBi Nutraceuticals Lindon, Utah 84042 USA. Bar Code: 3 58301 18118 9
D-0873-2018
Product summary
- Event
- Event 80119
- Status
- Terminated
- Classification
- Class II
- Quantity
- 134 bottles
- Official record key
drug-enforcement:D-0873-2018
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: 15050801, EXP 05/2018
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls