September 2020 FDA Recall Drug by Grato Holdings, Inc.
D-0099-2021 - Labeling

This Class III drug recall was voluntarily initiated by Grato Holdings, Inc. on September 17, 2020 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in UT and the recall is currently terminated.

Recall Number: D-0099-2021

Reason for Recall
Labeling: Product Contains Undeclared API; Incorrect formulation
Initiated
09-17-2020
Reported
11-25-2020
Quantity
399 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86690
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Grato Holdings, Inc.
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
UT
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-18-2022
Product Description About Product Description
Full technical description of the product.
Homeopathic Energy Catalyst, 1 fl oz (30 mL) Distributed by: Deseret Biologicals, Inc. 469 W. Parkland Drive Sandy, UT 84070. NDC 43742-0756-1.

Batch or Lot Expiration Information

Lot# s: Z60852, Z60012