Safety

Company Announcement

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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

Consumers

Christina Condon
Christina.Condon@SciRegs.com
(607) 859-2227

Consumers

C. Jeanne Taborsky
Jeanne.Taborsky@SciRegs.com
(607) 859-2227
 

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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

###

Product Photos

Product Photo: DG Baby Gripe Water - Primary and Supplemental Facts labeling

Page Last Updated: 02/15/2019
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English