BATON ROUGE, LA (WAFB) - The U.S. Food and Drug Administration is advising the public about recalls on a Gripe water product for infants and adults. The product was distributed throughout the United States by Dollar General Corporation.
The recall involves all lots of “DG™ Baby Gripe Water herbal supplement with organic ginger and fennel extracts.” The manufacturer, Kingston Pharma, is voluntarily recalling the product due to the presence of an undissolved ingredient, citrus flavonoid.
Officials say 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 reports it 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.
Consumers can identify the product by the following characteristics:
- The product is packaged in 4-ounce amber bottles
- The product has white plastic caps with safety seals
- The product is provided with an oral syringe
- The product has the UPC Code 8 5495400246 3
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 through the following methods:
- By phone - Call 1-800-332-1088
- Online - Complete and submit the report by clicking the link here
- By regular mail - Download the pre-addressed form by clicking the link here, then complete and return to the address
- By fax - Download the form by clicking the link here, then submit by fax to 1-800-FDA-0178