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On December 28, 2020, the FDA's official website announced a drug recall notice.
recalled the company as Sunstar's U.S. company.
founded in Japan and has grown into a global company headquartered near Lake Geneva, Switzerland.
currently operates in more than 20 countries, providing products and services to approximately 100 countries worldwide.
is a leader in the oral care industry, as well as manufacturers and distributors of the GUM and Butler brands.
. Sunstar voluntarily recalls Paroex®chloroethylene glucose oral lotion 0.12% USP for all products valid from December 31, 2020 to September 30, 2022.
the product may have been contaminated with Burkholderia lata.
October 27, 2020, the company announced a recall of some batches, a further recall of the incident.
risk of using this defective product may result in oral infections as well as potential systemic infections that require antimicrobial treatment.
in high-risk groups, the use of defective products can lead to life-threatening infections such as pneumonia and bacteremia.
so far, Sunstar has received 29 adverse events related to the recall.
berkhold infection in patients with the disease, which is usually found in sputum culture and is treated for other serious illnesses.
particularly unsafe to use contaminated products in patients with respiratory diseases, including those infected with Covid-19.
Recall This recall is a prescription product available only to medical professionals for the treatment of gingivitis, packaged as follows: 1789 PGUM®Paroex®: 6 amber bottles per box containing 16 ounces (473 ml) of chlorpyrine wash.
the bottle has a children's anti-theft cap and a 15 ml metered dose cup.
1788 PGUM®Paroex®: 24 bottles of amber in each case containing 4 ounces (118.25 ml) of chloramine wash.
the bottle had a child-proof cover.
recalls have been distributed nationwide to dental clinics, dental distributors, drug wholesalers, dental schools and pharmacies.
Sunstar of the United States notified its direct distributors and customers via express mail and is in the process of arranging a refund of all recalled products.
, pharmacies and medical institutions that own these products should immediately stop using and distributing them.
adverse reactions or quality issues encountered in using the product may be reported to the FDA online, by regular mail or fax, in accordance with the MedWatch Adverse Event Reporting Procedure.
the recall was made with the knowledge of the U.S. Food and Drug Administration.
Ref.:Sunstar Americas Inc. Expands Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination.December 28, 2020. Fda.