An herbal supplement for babies has been voluntarily recalled by Kingston Pharma, due to the presence of an undissolved ingredient. The product was distributed by Dollar General Corporation.
The company is recalling all of its lots due to what it says the presence of an undissolved ingredient, citrus flavonoid.
The company says the use of the product should be not be considered hazardous, but it says the use of the product could result in difficulty when swallowing the product for sensitive individuals.
Kingston Pharma says it received a report of a one-week-old infant having difficulty when swallowing the product and three complaints about the undissolved citrus flavonoid.
The product can be given to infants and adults.
The company says if you experience any problems related to the use of the product, please contact your doctor or healthcare provider.
Kingston Pharma says the recall is for 4-ounce amber bottles, white plastic caps with safety seals and oral syringes, with UPC Code: 8 5495400246 3.
MORE DETAILS FROM THE FDA:
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.
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, 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.