Why it was recalled
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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot: 15041402, No EXP date
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0867-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 15, 2018
- FDA report date
- Jun 20, 2018
- Quantity
- 121 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- MBi Distributing Inc. dba MBi Nutraceuticals
Original FDA data
Every field from FDA enforcement report D-0867-2018, exactly as published.
Show all FDA fields
- City
- Lindon
- State
- UT
- Status
- Terminated
- Country
- United States
- Event ID
- 80119
- Address
- 211 N 1800 W
- Code information
- Lot: 15041402, No EXP date
- Postal code
- 84042-1627
- Report date
- Jun 20, 2018
- Product type
- Drugs
- Recall number
- D-0867-2018
- Classification
- Class II
- Recalling firm
- MBi Distributing Inc. dba MBi Nutraceuticals
- Product quantity
- 121 bottles
- Termination date
- Jan 23, 2020
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 15, 2018
- Initial firm notification
- Press Release
- Center classification date
- Jun 14, 2018