The Kingston Pharmaceuticals LLC just issued a recall on Feb. 15 of Dollar General’s product Gripe Water due to possible choking hazard.
According to the company’s statement, the product, a herbal supplement containing organic ginger and fennel extracts for both adults and infants, contained citrus flavonoid, which is an undissolved ingredient.
Kingston Pharma, LLC Issues Voluntary Recall of All Lots of “DG™ Baby Gripe Water Due to Undissolved Ingredient, Citrus Flavonoid https://t.co/MXRwsyohm2
— U.S. FDA (@FDArecalls) February 15, 2019
The use of the product under normal circumstances, shouldn’t be considered hazardous, according to the statement, but “could result in difficulty when swallowing the product for sensitive individuals.”
According to the statement, there had been one incident where Kingston Pharma LLC had received a report that a one-week-old infant had difficulty while swallowing the product, and an additional three complaints resulted from the undissolved ingredient in the product.
The product, with the UPS Code 8 5495400246 3, is packaged in four-ounce amber bottles, which is sealed with a white plastic cap with a safety seal, according to the Food & Drug Administration’s similar statement. Provided along with the package is an oral syringe to administer the gripe water.
The FDA recalling all lots of the product, which is being distributed throughout the United States by the Dollar General Corporation.
The company is reaching out to all its customers about the recall with a press release on its website as well as on the FDA website, both releases encourage the consumers to stop using the recalled product and discard all units immediately.
“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 email Christina.Condon@SciRegs.com. Consumers should contact their physician or health care provider if they or their child have experienced any problems that may be related to taking or using this product,” the FDA statement read.
The consumer is asked to report any unfavorable reactions or problems with the quality of the product to the FDA’s MedWatch Adverse Event Reporting program, whether it is by phone, online, mail, or by fax. The FDA has provided, along with the mode of contact, the links, and the necessary paperwork to file the reports—all of which are on the released statement on its website.
Kingston Pharmaceuticals LLC is working together with The Food & Drug Administration to conduct the recall.
Recalled Products in 2019
In 2019, The FDA has issued 38 recalls for products—most of the items were recalled due to undeclared allergens such as eggs, nuts, and gluten.
However, there are two other cases of recalls related to risks of a choking hazard—Jansal Valley Dukkah and select WTRMLN WTR Original 12 Packs.
Sid Wainer and Son of New Bedford, Massachusettes, is issuing a recall for containers of Jansal Valley Dukkah, the Egyptian spice blend, due to potential glass pieces. The product is distributed nationwide and is packaged in a case of six individual containers. Each container contains 2.5 ounces, according to the FDA statement released on Feb. 15.
The FDA suggested that customers who have bought the product destroy it in order to prevent injury. So far, no injuries have resulted from the product.
On Feb. 8, World Waters issued a recall statement for its product, WTRMLN WTR, due to a potential choking hazard. The statement said that the product contained pieces of soft plastic that may be floating in some of the packaged products, according to the FDA.
The statement strongly encourages customers to check and inspect the products before consuming it. Similar to the recalled product Jansal Valley Dukkah, no injuries or problems have been reported.