D-0871-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 20, 2018
- Initiation Date
- May 15, 2018
- Termination Date
- January 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,971 bottles
Product Description
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
Reason for Recall
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot numbers: 16081901, EXP: 08/2018: 17031604, EXP: 03/2019; 17110901, EXP: 11/2019