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Kingston Pharma LLC Recall: Presence of an undissolved ingredient, citrus flavonoid.

United States

TerminatedClass I

Company
Kingston Pharma LLC
Product
DG Baby Gripe Water herbal supplement with organic ginger an…
Recall date
February 7, 2019
Terminated
July 17, 2019
Source
FDA

Reason for recall

Presence of an undissolved ingredient, citrus flavonoid.

  1. - Recall initiated
  2. - Reported by source
  3. - Recall terminated
Recalled products
Product description UPC Quantity Lot / code information
DG Baby Gripe Water herbal supplement with organic ginger and fennel extracts, 4 FL OZ (120 mL) Liquid Dietary Supplement UPC: 8 54954 00246 3 Not published in this source record 138,752 bottles All lot codes.

Distribution

  • USA: OH
  • FL
  • AZ
  • WI
  • MI
  • AL
  • CO
  • UT
  • NY
  • OK
  • CA
  • MO
  • IL
  • PA
  • CT
  • GA
  • TX
  • TN
  • NE
  • MA
  • OR
  • VA
  • NJ
  • IA
  • IN
  • KY
  • OK
  • LA
  • AR
  • KS
  • SC
  • MS
  • WV
  • NC
  • MD
  • DE
  • ME
  • MN
  • ND
  • NH
  • NV
  • RI
  • SD
  • VT

Official source record

Agency
FDA
Dataset
FDA Food Enforcement (Recalls)
Recall number
F-1171-2019
Event ID
82182
Status
Terminated
Classification
Class I
Company
Kingston Pharma LLC
Product description
DG Baby Gripe Water herbal supplement with organic ginger and fennel extracts, 4 FL OZ (120 mL) Liquid Dietary Supplement UPC: 8 54954 00246 3
Quantity
138,752 bottles
Reason
Presence of an undissolved ingredient, citrus flavonoid.
Recall initiation date
February 7, 2019
Report date
March 13, 2019
Classification date
Not published in this source record
Termination date
July 17, 2019
Distribution pattern
USA: OH, FL, AZ, WI, MI, AL, CO, UT, NY, OK, CA, MO, IL, PA, CT, GA, TX, TN, NE, MA, OR, VA, NJ, IA, IN, KY, OK, LA, AR, KS, SC, MS, WV, NC, MD, DE, ME, MN, ND, NH, NV, RI, SD, VT
UPC, lot, and code information
All lot codes.
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: Kingston Pharma LLC

Other recalls from Kingston Pharma LLC

FDA Recall United States Terminated Historical recordClass II

Kingston Pharma LLC

Product
DG health NATURALS For Infants 2+ Months+ baby Cough Syrup +…
Published
May 8, 2019
Distribution
Dollar General Stores

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FDA Recall United States Terminated Historical recordClass II

Kingston Pharma LLC

Product
Live Better Drug Free Black Elderberry Syrup, 4 FL OZ (118 m…
Published
February 21, 2018
Distribution
CVS Distribution Centers in the followin…

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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
Florida 1
Arizona 1
Wisconsin 1
Michigan 1
Alabama 1
Colorado 1
Utah 1
New York 1
Oklahoma 1
California 1
Missouri 1
Illinois 1
Pennsylvania 1
Connecticut 1
Georgia 1
Texas 1
Tennessee 1
Nebraska 1
Massachusetts 1
Oregon 1
Virginia 1
New Jersey 1
Iowa 1
Indiana 1
Kentucky 1
Louisiana 1
Arkansas 1
Kansas 1
South Carolina 1
Mississippi 1
West Virginia 1
North Carolina 1
Maryland 1
Delaware 1
Maine 1
Minnesota 1
North Dakota 1
New Hampshire 1
Nevada 1
Rhode Island 1
South Dakota 1
Vermont 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.

No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

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 I mean?

A situation in which there is a reasonable probability that use of or exposure to a product will cause serious adverse health consequences or death.

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 instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.

Where can I find more official information?

The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.

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.