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Merical, LLC Recall: Incorrect Probiotic blend indicated in the Supplemental Facts Panel on product label. - F-0193-2020

United States

TerminatedClass III

Company
Merical, LLC
Product
Leader Advanced Probiotic with 6 Probiotic Strains and 20 bi…
Recall date
October 31, 2019
Terminated
March 6, 2020
Source
FDA

Reason for recall

Incorrect Probiotic blend indicated in the Supplemental Facts Panel on product label.

  1. - Recall initiated
  2. - Reported by source
  3. - Recall terminated
Recalled products
Product description UPC Quantity Lot / code information
Leader Advanced Probiotic with 6 Probiotic Strains and 20 billion Live Cultures. 30 capsules Item Number: CARD40359, Product Number: 907019, UPC Code: 096295136654 Not published in this source record 442 cases Batch Numbers: 300-00027721 and 300-00027515, Pkg Numbers: 907727721 and 913327515, Expiration Dates: 08/2020 and 04/2021.

Distribution

  • One customer in OH who then distributed product nationwide

Official source record

Agency
FDA
Dataset
FDA Food Enforcement (Recalls)
Recall number
F-0193-2020
Event ID
84302
Status
Terminated
Classification
Class III
Company
Merical, LLC
Product description
Leader Advanced Probiotic with 6 Probiotic Strains and 20 billion Live Cultures. 30 capsules Item Number: CARD40359, Product Number: 907019, UPC Code: 096295136654
Quantity
442 cases
Reason
Incorrect Probiotic blend indicated in the Supplemental Facts Panel on product label.
Recall initiation date
October 31, 2019
Report date
December 4, 2019
Classification date
Not published in this source record
Termination date
March 6, 2020
Distribution pattern
One customer in OH who then distributed product nationwide
UPC, lot, and code information
Batch Numbers: 300-00027721 and 300-00027515, Pkg Numbers: 907727721 and 913327515, Expiration Dates: 08/2020 and 04/2021.
Voluntary or mandated
Voluntary: Firm initiated
Initial notification method
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Source last updated
Not tracked separately from the Public Health Trace retrieval date below
Public Health Trace retrieval date

Responsible company: Merical, LLC

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Distribution map

A map highlighting the states named in the source's distribution description.

Shading reflects state-level totals only, as published by the source. It does not imply county-level or point-level precision.

Distribution map
State Distributed
Ohio 1

States shown are extracted from the source's free-text distribution description above; a narrative description (e.g. "distributed nationwide") may not list individual states to extract.

Where this information comes from

View FDA enforcement record -- the specific openFDA record this summary was built from.

This record comes from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information. See FDA Enforcement Reports versus recall announcements for how that database differs from a press-release-style announcement.

New to reading a recall record? See how to read an FDA recall record and what recall statuses mean.

Technical source data

View raw source data -- the machine-readable record this page's information was built from.

Retrieved by Public Health Trace:

Frequently asked questions

What does a Class III mean?

FDA classifies this recall as Class III. See how to read an FDA recall record (linked above) for what each classification level means.

Is this recall still active?

According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this product?

Follow the responsible agency's published instructions, linked below -- recall guidance is set by that agency, not by Public Health Trace.

Official guidance and record verification

Public Health Trace does not provide medical advice -- review the linked official source below for current, authoritative information.

How to interpret this historical record

This record is preserved as published by FDA, as of March 6, 2020.

Status as reported: Terminated.

This page does not imply a current danger or a current consumer instruction -- review the official source for the most current information.

View the official FDA source

This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.

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