Xiaolin Chemical recalls 15 more drugs! Details: Picking the wrong material when making up for a violation

Xiaolin Chemical's official website issued a recall notice Xiaolin Chemical said that the recovery of these 15 drugs, the Ministry of Health, Labour and Fukui County government on the 21st and 22nd before the company's on-site investigation, asked to re-confirm the manufacturing process of the drugs;
Said in its recall notice that we are currently working on all products.
as part of our investigation, we investigated past test records and reported the results during an on-site inspection of the Administration on the 21st and 22nd of this month and found that many of the following products needed to be re-confirmed.
has confirmed that no product has been found to be in problem as a result of retesting the products stored in our company, and that we do not believe there is a serious risk to health, but that safety can be improved.
we will voluntarily recall it for the sake of integrity.
▍ the details of the mix: production due to wear and tear, employees when picking up the wrong material multiple links, but all failed.
(Photo from Japan's Nikkei News) According to Japan's Nikkei News, the mixed drug accident occurred around July this year, when officials added raw materials lost in the manufacturing process.
Kobayashi Kako explains that at this point, the container that should be placed in the main ingredient is mistaken for another container containing the sleep-inducing agent component.
, however, the original composition is packed in a thick paper container the size of a drum can, and the wrong shape is significantly different from that of a small square metal.
December 12, President Bobo had to admit his hasty, saying: "Overall, there is nothing wrong with that."
" Although the amount of raw material may be reduced due to attachment to the machine, resupply work is not permitted in manufacturing procedures approved by the Ministry of Health, Labour and Industry.
company's inspection function does not work.
, raw materials are stored in a warehouse, and the manager needs to double-check the quantity required for the process before taking them out.
company's rules, two people are required to point out and confirm when they come up with raw materials and weighing, but only one person in charge was working at the time.
the use of barcodes for computer management to prevent human error has become commonplace in the industry, but the company has adopted barcodes in another factory, which has not.
, before the tablets were shipped, the factory used a liquid chromatography to analyze the composition, with peaks showing how much it was made, according to the Asacodon Insight.
According to the Asa japanese news report, according to people familiar with the matter, in the test of the finished product, there has also been an unprecedented small chromatography peak, also thought it may be a foreign object mixed in.
site staff responsible for sample testing noticed changes in the test data and reported to their bosses that the levels of the main ingredients of the drug may vary.
, however, no detailed internal investigation has been carried out since then.
final quality check detects data indicating contamination of foreign property, but is ignored, in addition to the number indicating that the components of the sleep-inducing agent should not be added to the product.
▍ 21-22, the Ministry of Health, Labour and PMDA joint inspection 21-22, the Ministry of Health, Labour and Joint Independent Administrative Body "Pharmaceutical and Medical Device Organization (PMDA)," in accordance with the Drug and Medical Devices Law on-site inspection of Xiaolin Chemical, inspection ended at 8:30 pm on the 22nd.
, in addition to interviewing employees, we examined the materials and investigated the actual conditions of the manufacturing process that led to the contamination, as well as the inspection system that ignored the contamination.
studies to date have shown that, in addition to the products that are voluntarily recycled, there are also some drugs produced by processes that have not been approved by the Ministry of Health and Labour.
Ministry of Health, Labour and Industry plans to issue a closure order starting next month and will also decide on the suspension time after a careful review of the investigation.
on the 24th, Xiaolin Chemical announced the expansion of the recall shortly after the end of the on-site inspection.
Japanese pharmaceutical company Xiaolin Chemical produced oral drugs for the treatment of methicillin skin diseases, mistakenly mixed into sleeping inducers, known to have taken the drug 2 deaths, 34 people sent to hospital.
▍ expand the list of 15 drugs recalled