Kingston Pharma, LLC Issues Voluntary Recall of All Lots of “DG™ Baby Gripe Water Due to Undissolved Ingredient, Citrus Flavonoid
For Immediate Release
February 15, 2019
Contact
Announcement
Kingston
Pharma, LLC is voluntarily recalling all lots of “DG™ Baby Gripe Water
herbal supplement with organic ginger and fennel extracts” to the
consumer level due to the presence of an undissolved ingredient, citrus
flavonoid.
Use of
the product should not be considered hazardous but could result in
difficulty when swallowing the product for sensitive individuals. To
date, Kingston Pharma LLC has received one report of a one-week old
infant having difficulty when swallowing the product and three
complaints attributed to the undissolved citrus flavonoid.
The
product is administered orally to infants and adults. The recall is for
all lots. The product is packaged in 4-ounce amber bottles, white
plastic caps with safety seals and provided with an oral syringe, with
UPC Code 8 5495400246 3. The product was distributed throughout the
United States by Dollar General Corporation.
Kingston
Pharma, LLC is notifying its customers by press release of the recalled
product. Consumers that have product which is being recalled should
stop using and discard.
To
report adverse reactions or quality problems experienced with the use
of this product or to ask questions regarding this recall, contact
Christina Condon or C. Jeanne Taborsky by phone toll free at
844-724-7347 or by e-mail Christina.Condon@SciRegs.com.
Consumers should contact their physician or healthcare provider if they
or their child have experienced any problems that may be related to
taking or using this product.
Adverse
reactions or quality problems associated with the use of this product
may be reported to FDA's MedWatch Adverse Event Reporting program either
by phone, on line, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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