The product license of the Sulbacillin injection, an antibiotic by Daewoong Pharmaceutical Company has been revoked. The company confirmed the contaminated injections, yet still did not take necessary measures, such as an immediate stop of sales or a recall.
On August 8, the Ministry of Food and Drug Safety revoked the product license of Daewoong Pharmaceutical's 750mg and 1.5g Sulbacillin injections and suspended the manufacturing operations of the 0.6g Moxicle injection for three months.
The serial numbers of the 750mg Sulbacillin injections, which will have their license revoked are 586352 (manufacture date: Jan. 11, 2016), 587429 (Jan. 12, 2016), 587430 (Jan. 18, 2016) and 588450 (February 13, 2016), and the serial numbers of the 1.5g Sulbacillin injection are 586353 (January 19, 2016) and 587431 (Jan. 25, 2016).
The drug safety ministry judged that Daewoong did not take necessary measures as the one obligated to collect the products in question, such as immediately ending the sales of the drug subject to be recovered.
The latest administrative measure was triggered when a sterile plant was contaminated after Samsung Pharmaceuticals moved its GMP facility last April.
In the process, Sulbacillin and Moxible injections were exposed to the germs—Daewoong had commissioned Samsung to produce these products. Thus Daewoong, the owner of the license, inevitably had to dispose of its products.
But Daewoong explained that it took the company some time to finally confirm the problem, due to the differences in the way the company examined the products with the way applied by Samsung and that they had taken action as quickly as possible.
According to Daewoong, there are two approaches to test sterility: one is KP (Korean Pharmacopoeia) and the other is USP (the United States Pharmacopoeia). Samsung used the KP method to conduct the sterility test, while Daewoong used both KP and USP for overseas exports.
Daewoong was aware that their Sulbacillin injections were contaminated through its sterility test and notified Samsung (April 7). Samsung carried out another test, finally recognized the problem and explained that they would submit a plan to recover the products on August 14.
The company added that the drug safety ministry requested additional information, such as a recovery plan, from Samsung and also notified Daewoong to submit plans for the recovery of their products as the license holder. The company added that they submitted the information on April 19.
Daewoong notified Samsung of the results, that the Sulbacillin injection was inappropriate based on sterility, on April 7 and suspended the shipment from the plant and wholesale bases.
On April 14, the company submitted their recovery plan and resubmitted a revised plan on April 19. In addition, the company notified retail and wholesale stores and hospitals to stop using the product and informed them that the product was being recalled.
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