2023-04-25 13:04:31
As a result of collecting and inspecting Dong-A Pharmaceutical’s ‘Champ Syrup (acetaminophen)’, which had a browning phenomenon, two batch numbers were judged unsuitable.
The Ministry of Food and Drug Safety converted the item to ‘forced recall’ and took measures to ‘voluntarily recall’ the rest of the manufacturing numbers.
On the 25th, the Ministry of Food and Drug Safety said, “In order to check whether there are other quality problems with Dong-A Pharmaceutical’s Champ Syrup, which has recently caused browning, we directly collected and inspected commercially distributed products with browning concerns. “We strongly recommended voluntary recall of the rest of the manufacturing numbers,” he said.
The products with the above two lot numbers have the possibility of ‘browning’, so the company has already conducted a voluntary recall and has undergone a test to determine whether microorganisms (including specific microorganisms) such as bacteria and fungi are present in the product and, if so, how much is present.
‘Champ Syrup’ is a syrup that allows microbes below a certain level, and no disease-causing pathogens were detected in the subject of this forced recall, but more fungi were detected than the set standard.
Syrups are non-sterile, unlike sterile injections, and microorganisms below a certain level are allowed (microbial limit) in the same way in the United States, Europe, and Japan.
Dong-A Pharmaceutical is carrying out a voluntary recall of 16 batch numbers that it judged to be related to browning, including the two inappropriate lot numbers.
The Ministry of Food and Drug Safety temporarily suspended manufacturing and sales of the item, and distributed ‘Breaking News on Drug Safety’ to pharmaceuticals, pharmacists and consumers to stop using the product and switch to other alternative drugs.
This temporary suspension of manufacturing, sales, and use will be maintained until the appropriateness of Dong-A Pharmaceutical’s manufacturing and quality control is confirmed. Depending on the results of the investigation, if necessary, additional safety measures will be promptly implemented and notified.
In addition, according to this quality inconsistency, the Ministry of Food and Drug Safety instructed Dong-A Pharmaceutical to inspect all lot numbers of products at a testing agency designated by the Ministry of Food and Drug Safety to check the quality of all other lot number products of ‘Champ Syrup’ and submit the results. .
This measure is the result of the Ministry of Food and Drug Safety directly confirming the quality of ‘Champ Syrup’, and a separate investigation into the cause of browning will be completed quickly.
If there are any abnormal signs, such as side effects that are suspected to be related to ‘Champ Syrup’, you can immediately report them to the Korea Institute of Drug Safety and Risk Management.
In addition, Dong-A Pharmaceutical plans to return and refund the ‘Champ Syrup’ products that consumers have through pharmacies, etc., and also to refund online (Dong-A Pharmaceutical’s representative website).
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