COMPANY ANNOUNCEMENT
Kingston Pharma, LLC RECALLS " DG™/Health NATURALS Baby Cough Syrup + Mucus” Because of Possible Health Risk
This recall has been completed and FDA has terminated this recall.
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Read Announcement View Product PhotosSummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
-
Recall Reason DescriptionPotential to be contaminated with Bacillus cereus/ Bacillus circulans
- Company Name:
- Kingston Pharma, LLC
- Brand Name:
-
Brand Name(s)DG™/health NATURALS
- Product Description:
-
Product Descriptionbaby Cough Syrup + Mucus
Company Announcement
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 [email protected].
