A baby cough syrup is being recalled after the discovery of contamination from a known pathogen capable of causing vomiting and diarrhea.
DG™/health NATURALS baby Cough Syrup + Mucus is being voluntarily recalled, according to a notice from the Food and Drug Administration this week because of the presence of two types of bacteria: Bacillus cereus and Bacillus circulans.
The cough syrup is produced by Kingston Pharma, LLC of Massena, New York.
Testing of the product revealed that one in ten bottles indicated low levels of Bacillus cereus; two in ten bottles indicated low levels of Bacillus circulans. So far no illnesses have been reported in connection with the cough syrup.
Bacillus cereus is a well-known foodborne bacteria that produces toxins often resulting in vomiting, nausea, and diarrhea.
The other bacteria, Bacillus circulans, is also capable of causing infection but it less harmful.
Dr. Sunil Sood, chair of pediatrics at Northwell Health’s Southside Hospital, Bayshore, New York, lauded the recall effort.
“If you find any bacterial contamination in anything that goes in your mouth, a recall is definitely the right thing to do,” he told Healthline.
“Even if that particular bacteria or virus, whatever they find, is not likely to cause disease, who knows what else could have gotten into that same [product]? There was a source of contamination and that could imply that something else could have gotten in,” he added.
Bacillus cereus has had a reputation for decades as a cause of food poisoning. The bacteria is commonly associated with sickness from eating fried rice, so-called “.”
“The classic way this happens is that you order fried rice, often Chinese food, and you leave it out at room temperature on the kitchen counter and when you then go to reheat it the next day, these are bacteria that are in spores and they germinate with the reheating and can produce toxins that can cause vomiting or diarrhea,” said Sood.
Bacillus cereus food poisoning certainly isn’t limited to just one kind of food, although it’s common among those that are rich in starch.
Sood notes that because of the biologic processes that the bacteria must undergo, it’s unlikely that direct consumption from, in this case, cough syrup, is likely to result in sickness.
“It’s very unlikely that if you just swallow some Bacillus cereus straight that it’s actually going to germinate in your stomach and cause disease. So, it’s probably going to be completely harmless because that’s just not the mechanism of how it causes food poisoning. It has to go through those two stages,” he said.
This is true, even for babies, he added.
Nonetheless, this bacteria is capable of causing potentially fatal infections under the right circumstances, particularly among newborns and the immunocompromised.
“Outside its notoriety in association with food poisoning and severe eye infections, this bacterium has been incriminated in a multitude of other clinical conditions such as anthrax-like progressive pneumonia, fulminant sepsis, and devastating central nervous system infections, particularly in immunosuppressed individuals, intravenous drug abusers, and [newborns],” study authors wrote in an in 2010 in Clinical Microbiology Reviews on the bacteria.
Production of DG™/health NATURALS baby Cough Syrup + Mucus has been suspended until the manufacturer can investigate the source of the problem.
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.
Concerned parents and those that have purchased the product are urged to return them to the place of purchase for a full refund. Consumers can further contact the company at 1-844-724-7347 8:30 a.m. to 6:00 p.m. EST or email at Christina.Condon@SciRegs.com.
The company declined a request from Healthline for an additional comment.
The baby cough syrup DG™/health NATURALS baby Cough Syrup + Mucus is being recalled due to contamination from two known bacterial pathogens: Bacillus cereus and Bacillus circulans. No known illnesses have occurred from the medication.
Bacillus cereus can cause symptoms typically associated with food poisoning, such as nausea, vomiting, and diarrhea. It has the potential to cause more serious symptoms in newborns and the immunocompromised.
However, it is unlikely that exposure to the bacteria in the product is likely to result in sickness.
“I would reassure [parents] that it’s probably not even going to cause any vomiting or diarrhea,” said Sood.
Concerned parents and those that have purchased the product are urged to return them to the place of purchase for a full refund.