(WPRI) — Kingston Pharma, LLC is recalling all lots of DG Baby Gripe Water.
According to the Food and Drug Administration, the recall is due to the presences of an undissolved ingredient – citrus flavonoid – which could make it difficult for babies to swallow. The agency said the product is not considered hazardous.
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 – which is used to help soothe colicky babies – 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.
The FDA said consumers who have the recalled product 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.