April 2020 FDA Recall Drug by Summitt Labs
D-1489-2020 - Chemical Contamination; product contains elevated levels of lead

This Class I drug recall was voluntarily initiated by Summitt Labs on April 15, 2020 for the product Drug. The FDA reported the reason for recall as chemical contamination; product contains elevated levels of lead. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1489-2020

Reason for Recall
Chemical Contamination; product contains elevated levels of lead
Initiated
04-15-2020
Reported
08-12-2020
Quantity
236 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85574
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Summitt Labs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-19-2022
Product Description About Product Description
Full technical description of the product.
KORE ORGANIC CBD Oil Watermelon 15mg*, 30 mL dropper bottles, Handcrafted By Summitt Labs, UPC 8 5765000812 8, www.KOREORGANIC.com 833.810.KORE.

Batch or Lot Expiration Information

Lot# 730
Lot# K018, Exp. 8/20