HUNTSVILLE, Ala. – The U.S. Food and Drug Administration recalls gripe water distributed throughout the United States by Dollar General Corporation.
Kingston Pharma, LLC is 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.
Officials say the product is not considered hazardous but could result in difficulty when swallowing the product for sensitive individuals.
The recalled product has the following features:
- The product has the UPC Code 8 5495400246 3.
- The product was distributed throughout the United States by Dollar General Corporation.
- The product is packaged in 4-ounce amber bottles.
- It has white plastic caps with safety seals and an oral syringe.
To date, Kingston Pharma LLC 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 that have the recalled product should stop using and discard. Consumers are also encouraged to 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.
For problems associated with this product, report to the FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form at 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.