Why it was recalled
Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine.
Product description
Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 mg tablets; Packed in a 75 cc HDPE Bottle 60 Tablets UPC: 8 28054 17845 8; SKU: ML1
Lot numbers, UPCs & expiration codes
FG Lot 2018410057; Expiration Date 8/2020
Where it was sold
One customer in KS.
What to do if you have this product
- Compare the brand, size, and lot/UPC codes on your package with the codes above.
- If it matches, don't eat it. Return it to the store for a refund or throw it away.
- Wash surfaces and containers that touched the product.
- If you feel sick after eating it, contact your doctor. In an emergency call 911.
Recall details
- Recall number
- F-1101-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 17, 2019
- FDA report date
- Mar 6, 2019
- Quantity
- 120 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ProThera, Inc. dba SFI USA
Original FDA data
Every field from FDA enforcement report F-1101-2019, exactly as published.
Show all FDA fields
- City
- Reno
- State
- NV
- Status
- Terminated
- Country
- United States
- Event ID
- 82010
- Address
- 795 Trademark Dr
- Code information
- FG Lot 2018410057; Expiration Date 8/2020
- Postal code
- 89521-5920
- Report date
- Mar 6, 2019
- Product type
- Food
- Recall number
- F-1101-2019
- Classification
- Class III
- Recalling firm
- ProThera, Inc. dba SFI USA
- Product quantity
- 120 bottles
- Termination date
- Mar 26, 2019
- Reason for recall
- Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 mg tablets; Packed in a 75 cc HDPE Bottle 60 Tablets UPC: 8 28054 17845 8; SKU: ML1
- Distribution pattern
- One customer in KS.
- Recall initiation date
- Jan 17, 2019
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Feb 27, 2019