Kingston Pharma, LLC of Massena, NY is recalling Lot KL180157 of its 2-fluid ounce (59 mL) bottles of DG™/health NATURALS baby Cough Syrup + Mucus” because it has the potential to be contaminated with Bacillus cereus/ Bacillus circulans. Bacillus cereus in food products has the potential to produce two forms of gastrointestinal illness, one being a syndrome primarily of vomiting, and the other of diarrhea. Most often, illnesses are mild and self-limiting, although more serious and even lethal cases have occurred. Individuals at risk for more severe forms of illness include infants, young children, and others with weakened immune systems. No illnesses have been reported to date in connection with this problem with the use of DG™/health NATURALS baby Cough Syrup + Mucus.
The recalled DG™/health NATURALS baby Cough Syrup + Mucus” bottles were distributed nationwide in Dollar General retail stores. The product comes in a carton labeled DG™/health baby Cough Syrup + Mucus in 2-fluid ounce bottles marked with Lot KL180157 Expiration date 11/20 on the bottom of the carton and back of the bottle label; UPC Code 8 54954 00250 0.
The potential for contamination was noted after audit testing revealed the presence of Bacillus cereus /Bacillus circulans in some bottles of this lot of the product. One in ten bottles showed low levels of Bacillus cereus and two in ten bottles showed low levels of Bacillus circulans.
Production of the product has been suspended while FDA and the company continue their investigation as to the source of the problem.
Consumers who have purchased Lot KL180157 of DG™/health NATURALS baby Cough Syrup + Mucus” may return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-844-724-7347 8:30 a.m. to 6:00 p.m. EST or e-mail at Christina.Condon@SciRegs.com.
Read more for Kingston Pharma LLC, DG Gripe Water recall information.
Kingston Pharma, LLC is voluntarily 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.
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, LLC is notifying its customers by a press release dated from Feb. 2019 for this recalled product. Consumers that have the 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: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
- Regular Mail or Fax: Download the 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.
- Toll-free number 844-724-7347
- e-mail Christina.Condon@SciRegs.com or Jeanne.Taborsky@SciRegs.com