Toll free number 844-724-7347
e-mail Christina.Condon@SciRegs.com or Jeanne.Taborsky@SciRegs.com
Kingston Pharma, LLCis voluntarily recalling all lots of “DG™ Baby Gripe Water herbal supplement with organic ginger and fennel extracts” to the consumer leveldue to the presence of an undissolved ingredient, citrusflavonoid.
Use of the product should not be considered to be hazardous but could result in difficulty when swallowing the product for sensitive individuals. To date, Kinston 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 product is packaged in 4-ounce amber bottles, white plastic caps with safety seals and provided with an oral syringe. The recall is for all lots. The product was distributed throughout the United States by Dollar General.
Kingston Pharma, LLCis 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 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 experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, 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.
Date: April 2, 2019
Kingston Pharma, LLC RECALLS " DG™/health NATURALS baby Cough Syrup + Mucus” Because of Possible Health Risk. Click here for more details